CN102781378B - In hyperthermia process or optionally cool the extracorporeal blood treat-ment apparatus of brain, system and method in the process of induction brain low temperature relative to health - Google Patents

Abstract

The invention provides the system of an extracorporeal blood treatment, equipment and method, particularly set up and maintain the temperature difference of below cervical region, keep close to normal brain temperature simultaneously, to protect brain from adding for a long time or the impact of extreme low temperature or thermotherapy.The control that a kind of equipment of haemodialysis and system provide brain temperature and the following temperature of neck portion of body is poor.Such as, for the bypass circuit that first of brain blood circulation has heat exchanger, one is maintained close to normal blood heat, and for second bypass circuit sanguimotor below cervical region, then provide heat treatment to guide temperature difference, such as, relative to thermotherapy or the low temperature therapy of cerebral circulation.The application of these systems and equipment is, such as, uses thermotherapy Diagnosis and Treat, particularly to the treatment under the high temperature added for a long time or more than 42 DEG C, more such as, uses thermotherapy treatment cancer, the disease that infective bacterial or virus cause.

Description

In hyperthermia process or optionally cool the extracorporeal blood treat-ment apparatus of brain, system and method in the process of induction brain low temperature relative to health

Cross-referenced relevant application

The U.S. Provisional Application 61/164 that this application was submitted on March 30th, 2009,713 have priority.This provisional application is entitled as " Neck Down Induced Hyperthermia withbypass cooling to the brain; for the treatment of Cancer; HIV and otherDiseases " (" induce thermotherapy to carry out bypass cooling to brain below cervical region; to be used for the treatment of cancer simultaneously, acquired immune deficiency syndrome (AIDS) and other diseases ".) it should include the application in scope in as a reference.Technical field

The present invention relates to Induced hyperthermia or low temperature field for medical therapy and diagnostic purpose.The invention particularly relates to the biomedical devices for extracorporeal blood treatment, system and method and the body temperature with foundation and maintenance one rising carry out thermotherapy treatment cancer, acquired immune deficiency syndrome (AIDS) and other diseases.

Background technology

The normal body temperature of human body, is also referred to as room temperature or thermophilic, and it depends on and to measure at which body part, and you one day when carry out measure and the level of activation of a people.The different parts of health has different temperature.Take body cavity directly to measure usually to measure a little more than oral cavity, oral cavity is measured then a little more than skin temperature.Generally accepted average core temperature (in-vivo measurement) is 37.0 DEG C (98.6 °F).Typical oral cavity (Sublingual) measurement is 36.8 ± 0.7 DEG C, or 98.2 ± 1.3 °F.

Autotelic cooling reduces body temperature thus a kind of method setting up low temperature state has a lot of benefit, such as, can slow down metabolic processes and reduce oxygen consumption, and to reduce oxygen consumption be very useful in the medical therapy such as operation on heart.

Create the method for an elevate body temperature with heat, namely thermotherapy is as the means of a kind of Therapeutic cancer and other diseases, is approved since ancient times always and study by people.Recently, thermotherapy has been reported in the treatment under a series of condition useful, comprising: cancer, HIV (human immunodeficiency virus)/acquired immune deficiency syndrome (AIDS), hepatitis C, chronic inflammation disease is as ulcerative colitis and Crohn disease, rheumatism, bronchial asthma, chronic and recurrent viral infection, and need the case of removing toxic substances, and herpes simplex virus.

In the international conference of first time tumor thermotherapy held in Washington for 1975, thermotherapy causes the attention in the whole world as the means of Therapeutic cancer.Interior-heat treats one of effective means being proved to be Therapeutic cancer in the past few decades, no matter is treat separately or use with the other treatment such as radiotherapy or chemotherapy method simultaneously.

In fact, everybody has realized that the cell of interior tumor cell compared with normal health is to heat more responsive [1,2].Realization is the temperature between 40 DEG C to 44 DEG C to the lethal effect of tumor cell.When temperature is higher than 42.5 DEG C to 43 DEG C, often increases by 1 DEG C with temperature and give the time of exposure that equal cell kills and can reduce by half [2].When temperatures as high 44 DEG C, hyperthermia treatment is after 1 hour, and most of normal cell still remains intact [3] with organizing.

Induction thermotherapy has multiple different mode.Local thermotherapy induces by the energy source of outside or inside.Region thermotherapy can be realized by organ or limb perfusion or poured into by body cavity.Whole-body hyperthermia, also can be used on cancerous cell and has been diffused into it the patient of several different parts.

The therapeutic effect of thermotherapy is relevant with the length for the treatment of time and the characteristic of biological cells and tissues with temperature reached over the course for the treatment of.When thermotherapy, if temperature remains under 111 °F or 44 DEG C, normal structure generally can not be damaged.Therefore, improve as far as possible the temperature of tumor controlled to the temperature of surrounding health tissue be 44 DEG C or lower temperature time be very useful.

local thermotherapy:

With local thermotherapy, energy source can make the temperature of tumor be locally heated and improve.Also there be certain heating in local thermotherapy to organizing of tumor vicinity.But being difficult to ensure when whole tumor is exposed on sufficiently high temperature can not tissue around excessive heat tumor.In addition, if tumor locus heating not, some cancer cell survives after the treatment, and they can continue procreation.

region thermotherapy:

Region thermotherapy be some position of high-temperature heating health as organ, limbs, or body cavity.It generally will carry out in conjunction with chemotherapy or radiotherapy.Have a kind of method, be called regional perfusion, it, by the blood supply of isolation health part, uses this part blood of heating devices heat, then this part blood pump of heating is got back to original position.Studying this method some cancer on treatment arm or lower limb at present.

Similar technology is just tested in belly cavity tumor operation.In operation process, heating chemotherapeutics is transmitted by abdominal cavity.So-called continuous abdominal cavity thermotherapy perfusion that Here it is, or be CHPP.

The method also having a region thermotherapy is exactly deep tissue thermotherapy.The method uses radio frequency or being oriented in a specific region by the high-energy ripple that it produces by the microwave radiation device being placed on organ or body cavity surface treats.

whole-body hyperthermia:

Whole-body hyperthermia is as to making a kind of more effective method of chemotherapy also just studied in metastatic cancer patient treatment.The raising of body temperature is by using warm water blanket, inductance coil (resembling on electric blanket), or hot cell (the spitting image of a large couveuse) has come.

Moderate whole-body hyperthermia can stimulating immune system.Cause nature fever by improving core temperature to about 39.5 DEG C (103.1 °F), this turn increases n cell conversely, the quantity of t helper cell and cytotoxic T cell and activity.This Therapeutic Method also can be used for the renal cell carcinoma having particular associative with immune system, malignant melanoma and special lymphoma.This method also may be used for the recurrence preventing cancer.

Limit whole-body hyperthermia is combined with chemotherapy usually, treatment late period or metastatic cancer.The core temperature of health is raised to 42 DEG C (107.6 °F).This method is very useful to advanced cancer therapy, especially transfers to liver to cancerous cell, the patient of the Different Organs such as skeleton or pulmonary.

After being combined with whole-body hyperthermia, chemotherapy has been proved to be more effective.The temperature that chemotherapy starts is at about 41 DEG C (105.8 °F).Usually, when chemotherapy combines with thermotherapy, the chemotherapy of very low dosage can be used, thus its side effect is minimized.By in conjunction with chemotherapy and whole-body hyperthermia, we successfully can treat tumor or the metastatic tumo(u)r of anti-chemotherapy.

thermotherapy is to the treatment of HIV (human immunodeficiency virus) and acquired immune deficiency syndrome (AIDS)

Research finds that thermotherapy has some effects in treatment HIV (human immunodeficiency virus) and acquired immune deficiency syndrome (AIDS) and other its virus possible or the infectious disease of antibacterial to sensitive.Some researchs completed show in 10 years in the past, and whole-body hyperthermia is a kind of means for the treatment of acquired immune deficiency syndrome (AIDS) likely.

Such as, Alonso reports the long-term results [4] to disposable low discharge (0.3 liter/min) the Cardiopulmonary bypass thermotherapy having 29 male of sporadic Kaposi sarcoma and degree of depth immunologic injury and 2 women to carry out.The degeneration-resistant viral therapy that turns stops at thermotherapy treatment for first 72 hours, and stops using in follow-up period.They, with by the temperature-controlled process of external heating blood to 49 DEG C, carry out Cardiopulmonary bypass, thus make core temperature bring up to 42 DEG C and keep one hour.In 31 routine patients, there are 2 examples because of the treatment (arrhythmia of complication; Central nervous system is hemorrhage) and dead.Two examples are had to occur the situation of intravascular coagulation.After the treatment of 30 days, tumor diminishes phenomenon wholly or in part, after treatment after 120 days, has 14 to occur that tumor continues the phenomenon that diminishes in 29 patients to have 20 to occur in 29 patients.After the treatment of 360 days, tumor diminishes phenomenon and 1 occurs cases of complete remission phenomenon (after 26 months) to have 4 to occur in 29 patients.The patient of this cases of complete remission presents cultivation (culture) feminine gender and polymerase chain reaction (PCR) feminine gender of HIV (human immunodeficiency virus), and his cd4 cell counting also rises to about 800 from about 250.Selected healing of focus biopsy shows tumor disappearance.If patient has the phenomenon that diminishes after tumor biopsy test is presented at external beat exposure before the treatment, patient will be participated in treatment by selection.Show the failed analysis of cases of early and middle portion if total cd4 cell counting of patient is lower than 50, and remain on so low level for a long time, so his cd4 cell counting seldom can present lasting rising.Show the analysis of the responseless minority tumor patient of thermotherapy, their IL-6 (cytokine 6) level is compared those tumor patients responded to thermotherapy and raises (12 contrasts are less than 1 pg/ml).At thermotherapy treatment after 120 days, have in 31 patients 29 still live (being expected to be 20 people).At thermotherapy treatment after 360 days, have in 31 patients 21 still live (being expected to be 11 people).Patient's acquired immune deficiency syndrome (AIDS) after thermotherapy is not had to become more serious.The people such as Alonso notice those have severe immune deficiency and the very low patient of cd4 cell counting, thermotherapy to raising cd4 cell counting and lymphocytic effect not remarkable, and concerning the higher patient of cd4 cell counting (300 or higher), treatment after observe, thermotherapy to raising cd4 cell counting and lymphocytic effect very remarkable.

In the clinical trial that Alonso and his colleagues carry out, they use low discharge (0.3 liter/min) Cardiopulmonary bypass mode of heating to carry out thermotherapy.Perfusion cannula is inserted into femoral artery and another perfusion cannula is inserted into the femoral vein of contrary limbs.Blood flow is pushed in a roller pump by the arteriotony of patient self, is then heated to 49 DEG C by heat block, then is re-inserted in the femoral vein of contrary limbs.Use blood heat meter, rectal thermometer and intramuscular injection thermometer monitor the body temperature of patient simultaneously.

Thermotherapy was become a kind of means of the treatment acquired immune deficiency syndrome (AIDS) of U.S. FDA approval by Steinhart afterwards.In the thermotherapy test of first FDA approval, Steinhart registers six men, and their CD4 counting has KS pathological changes lower than 200, at least three people.Participant has carried out the whole-body hyperthermia of a hour 40 DEG C or 42 DEG C.Any adverse side effect is not found at observation treatments period.KS pathological changes partial remission immediately after whole-body hyperthermia, but have five people after one week, to turn back to the front level for the treatment of.And the treatment cooled immediately after 42 DEG C are heated to this five people, their hiv rna is significantly reduced.

Also there are some sizable research institutions, establish the sensitivity of HIV (human immunodeficiency virus) to temperature.HIV (human immunodeficiency virus), the same as with other enveloped virus responsive to temperature, in one section of given time span, along with progressively increasing more than temperature to 37 DEG C, HIV (human immunodeficiency virus) will be subjected to very large inactivation [5].The research of the people such as Spire shows that the HIV (human immunodeficiency virus) of 40% is inactivated [6] after staying upper 30 minute in tepidarium.The people such as McDougal then illustrate the killed linear relationship daily record [7] of the HIV (human immunodeficiency virus) from 37 DEG C to 56 DEG C.The research of the people such as Marcial-Vega (Marshall-Wei Jia) shows, if under a HIV sufferers is exposed to the high temperature of 42 DEG C in two hours, so his all viruses (its concentration can reach 800 ngs/ml) and the cell of all infection will be killed [8] effectively.The research of the people such as Wong finds that the cell of HIV (human immunodeficiency virus) infection virus is more sensitive to hot injury compared with the cell of uninfection, and this sensitivity is caused by TNF A.Second benefit of whole-body hyperthermia is, along with the rising of body temperature will stimulate the generation [9,10] of antibody.The research of Here it is why Alonso shows that CD4 counts the reason only having the patient of 200 CD4 after whole-body hyperthermia to increase to some extent.

Show based on above-mentioned research, heating or thermotherapy are a kind of methods of up-and-coming treatment acquired immune deficiency syndrome (AIDS).Although also without any reporting that this virus is by situation about eliminating completely, the previous work progress of whole-body hyperthermia has proved that whole-body hyperthermia has the ability to slow down the progress of acquired immune deficiency syndrome (AIDS), extends patient vitals.In addition, have the large research institution of object research HIV (human immunodeficiency virus) to temperature sensitivity to show, the whole-body hyperthermia within the scope of 42 DEG C can kill the cell [8] of all virus and infection effectively.

Increasing research institution begins one's study and treats hepatitis C with whole-body hyperthermia in recent years.In 2002, Dutch liver longevity fund (NLF) initiated a clinical trial, to assess whole-body hyperthermia as a kind of method for the treatment of hepatitis C.This test is propped up hepatopathy medical center and is carried out in Utrecht.Use whole-body hyperthermia treatment hepatitis C and with whole-body hyperthermia treatment HIV (human immunodeficiency virus) similar.As discussed above, preferentially kill hepatitis C virus under the high temperature conditions, and stimulate its immune system, second benefit of thermotherapy that Here it is.

other diseases

Should also be noted that thermotherapy also may be used for treating other diseases.The pathogen of any infectious disease finds that there is after being heated dysgenicly all likely treats by thermotherapy.In addition, because immune system can stimulate by upborne core temperature, so or even temperature-resistant infectious disease, thermotherapy is also very helpful.

Therefore, generally speaking, whole-body hyperthermia can be induced the temperature up to about 42 DEG C.When core temperature is found Therapeutic cancer up to 42 DEG C or when being low to moderate 39 DEG C in some cases, acquired immune deficiency syndrome (AIDS), hepatitis C and animal infectious diease or chronic disease are effectively.Thermotherapy treatment cancer has been brought into use in much research, and thermotherapy is a quite new field to the use that HIV (human immunodeficiency virus) is treated, but has demonstrated some gratifying achievements.Thermotherapy is also used to treat many chronic inflammation diseases as ulcerative colitis and Crohn disease, rheumatism, bronchial asthma, chronic and recurrent viral infection, more even needs the situation of removing toxic substances chronic inflammatory disease.

But as you know, no matter in the therapeutic process of low temperature or high temperature, brain is more more responsive to variations in temperature than other positions of health.Although in some cases, brain be found to bear low reach 30 DEG C add long low temperature therapy, i.e. the low temperature therapy of lower than normal body temperature 7 DEG C.But well-known, brain is difficult to resist the similar temperature difference higher than normal body temperature, the Microwave of even long-time more than 42 DEG C, is difficult to accomplish without extensive damage or do not have life-threatening risk.There are some researches show, when core temperature reaches 41 DEG C, the brain of people starts to occur damaging.The infringement of brain, and the physiological reaction caused by hypothalamus are the key points that restriction improves more than human body temperature to 42 DEG C.

Therefore, in use thermotherapy treatment cancer, in the process of acquired immune deficiency syndrome (AIDS) or other diseases, protect the brain of patient just to become a kind of needs from the adverse effect of thermotherapy.

As an example, whole body thermotherapy system is disclosed in following patent, one is No. 5817045, the United States Patent (USP) of Sever, be entitled as " equipment and the method for the whole blood circulation supply of the patient that at least half lives being carried out to external treatment in a continuous print interval ", one is No. 5074838, the United States Patent (USP) of the people such as Kroyer, is entitled as " the extrinsic heat therapy equipment and the method that use penetrating agent disease therapy ".

Lennox is at his No. 7241307, United States Patent (USP), be entitled as the method disclosing only Local cooling head under low temperature therapy in " method and apparatus of management patient temperature ", such as at treatment brain injury, apoplexy, or during sudden cardiac arrest, use a conduit system to take out a part of blood, cool, then refill this part blood and get back in system, this repetitive process provides limited temperature and controls.As mentioned above, this system will have problem to thermotherapy treatment, because the health blood flow of heating directly can enter brain in pump-back system process, thus cause potential adverse effect to brain.

Such as; Yee, at his No. 6669661, United States Patent (USP), is entitled as in " when whole-body hyperthermia or low temperature therapy to the neural protector of central authorities and method " to disclose a kind ofly attempt to solve in hyperthermia process, how to protect the system and method for brain and nervous-system problems.But this system is not only complicated and expensive, and this process relates to anesthesia and central nervous system and circulates and being thoroughly separated of health remainder, and this brings many relevant risks to patient.

For the thermotherapy treatment lengthened, need to avoid many interventions extremely, such as, to the situation of being obstructed that should reduce its normal blood circulation during a conscious patient as far as possible, brain should be protected from the too high impact of temperature simultaneously.

Therefore, we need a kind of extracorporeal circulation of blood treatment facility of improvement, system and method, set up and maintain the Diagnosis and Treat of thermotherapy with this.

The object of the invention is to overcome or be at least improve one or more known devices, the defect of system and method, or a new selection is at least provided.

Summary of the invention discloses:

One aspect of the present invention provides a high-temperature processing method, and feature brings up to higher than normal core temperature by the body temperature below cervical region in thermotherapy, keeps the temperature of brain lower than the body temp below cervical region simultaneously.

We should preferentially should be mentioned that, the method comprises: carry out the blood flow of external cooling from health to brain by least one carotid artery and carry out the blood backflow of external heating from brain to health by least one jugular vein, such as, thermotherapy is carried out by the suitable extracorporeal circulation of blood bypath system with cooling and heating function.The method preferentially provides the vascular pressure how keeping internal carotid artery enough, by the carotid artery flow of cooling by this circulating transfer of Willie in the cerebrovascular provided by vertebra and basilar artery.

The present invention provides the Therapeutic Method of a kind of low temperature or high temperature (thermotherapy) on the other hand, feature be below cervical region heating or cool at least health a part to higher or lower than a normal core temperature, keep a relatively normal brain temperature simultaneously.The feature of the method is: by the blood flow of carotid artery shunting from heart to brain, this needs by an extracorporeal circulation of blood bypath system, this system comprises a heat exchanger, it can heat or cool the temperature that blood flow is wanted to you, then the blood flow of heating or cooling is sent back in carotid artery, thus provide the temperature difference at a brain and other position of health.

We should preferentially should be mentioned that, the method also comprises the blood flow being flow to health by jugular vein shunting from gyri cerebri, by second extracorporeal circulation of blood bypath system, heat or cool this part blood flow to temperature required, to maintain the required normal body temperature of below cervical region.Such as, heatable body from neck, cools the blood flow of carotid artery flow to brain simultaneously.In best enforcement, the method keeps the thermotherapy state under neck under being included in the temperature of a setting, cool from brain to carotid blood flow simultaneously, to maintain a normal brain temperature, the temperature of whole-body hyperthermia so just can be made to bring up to more than 42 DEG C.

This method also applies to the disease for the treatment of other cancer forms, HIV (human immunodeficiency virus) infection or the viral infection relevant to acquired immune deficiency syndrome (AIDS), thermo-responsive virus or bacteriological infection, and may comprise the chemotherapy under management health thermotherapy state.

If needed, this method can also provide a Local cooling part or manifold pulmonary, spinal cord, the thermo-responsive position of testis and other healths and tissue.

Another aspect of the present invention additionally provides a thermotherapy treatment system: feature is that it provides will carry out the method for external cooling by least one carotid artery from the cerebripetal blood of health stream; Or optionally by least one jugular vein, the blood flowing back to health from brain is carried out the method for external heating; Control the blood flow temperature from carotid artery to brain simultaneously, during to remain on whole-body hyperthermia under neck, maintain the method for a normal brain temperature.

Another aspect of the present invention further provides an external blood circle treatment system: feature for it be an artery blood flow bypath system circuit, this circuit has input medium-be used for and receives the artery blood flow flowed out from health; Also there is output means-be used for that the blood flow of cooling is refilled carotid artery then to flow to brain; It also has heat exchange means-be used for and regulates the temperature flowing cerebripetal blood from bypath system to carotid artery again; There are the means of pump-be used for controlling to flow cerebripetal blood flow velocity and pressure again from bypath system to carotid artery simultaneously; It also has the means of sensor-be used for monitor temperature from bypath system input and output blood flow, flow velocity and pressure; With control device-being used for controlling to output to carotid artery from bypath system flows cerebripetal blood flow temperature, flow velocity and pressure again.

We should preferentially should be mentioned that, the further feature of this system is: it is a venous blood flow bypass circuit, and this circuit has input medium-be used for and receives the venous blood flow flowed out from brain; Also there is output means-be used for the blood flow of heating to re-inject in jugular vein, then flow to health; It also has heat exchange means-be used for regulating the temperature flowing to the jugular vein blood of health just now mentioned; There is venous blood flow that control device-further provide controls the to export blood flow temperature to health simultaneously.

Control device has operability, and it is used to set up and maintain the body temperature of below cervical region and the gap of brain temperature, and the thermotherapy of such as carrying out below cervical region within predetermined treatment time maintains normal brain temperature simultaneously.Temperature difference can regulate and control with computer software in a treatments period.

Sensor means is used to provide receiving flag the data of core temperature and brain temperature, wherein control device is used to keep the artery blood flow of input and output to the temperature difference required between jugular blood flow, thus provides the required temperature difference between core temperature and brain using warming therapy.

Venous bypass circuit includes a similar pump and sensor, is used for monitor and forecast temperature, pressure and be back to the blood flow of whole body from brain through internal jugular vein.

Another aspect of the present invention also further provides an extracorporeal circulation of blood treatment facility having chiller for thermotherapy.Its feature is: it has an artery blood flow bypass circuit, and the input and output blood flow that it can receive from the artery blood flow of health passes to brain again to carotid artery; It has one by the pump of bypass circuit blowback blood system; A refrigerating plant and heat-exchange device, to be cooled through the blood flow of bypass circuit; A temperature sensor, is used for monitoring the blood flow temperature of input and output; A pressure transducer, is used for monitoring the blood stream pressure of input and output; A control device, is used for monitor temperature, and pressure and flow parameter and regulating and controlling temperature, pressure and flow, to guarantee that the blood flow exported is delivered to tremulous pulse and arrives the temperature of brain again lower than the artery blood flow temperature inputted from health.

This equipment can comprise a corresponding heater-heat the blood flow returning health from brain further, or this equipment can comprise another chiller-to regulate from brain to heart and the blood heat of pulmonary.

In addition, this equipment can comprise a tremulous pulse or venous blood flow bypass circuit, and it has a heat exchanger comprising heating and cooling element, with the blood flow temperature of regulation output more higher than or more lower than input blood heat.

At a core temperature higher than in the thermotherapy of 44 DEG C, perhaps the venous blood flow that a cooling part is back to heart is very favourable, because the venous blood flow temperature being back to heart and pulmonary is always a little less than the core temperature below cervical region.So just likely make most of Body contact of below cervical region to more high temperature, keep heart to have lower temperature with the blood flowing to pulmonary simultaneously, thus delay the untoward reaction of morbidity, as sudden cardiac arrest.

Therefore, according to various aspects of the present invention, the method, system and equipment allow the core temperature of below cervical region be enhanced and maintain in this higher temperature, and brain is then in lower temperature, or best, be in close at normal temperature, thus the maximum temperature allowed in thermotherapy treatment is increased, or, the persistent period for the treatment of is extended.By keeping the temperature difference of brain temperature and body temperature, thus reduce the risk of brain injury, and overcome the physiological reaction caused by hypothalamus, this improves the mainly restriction of body temperature more than 42 DEG C.Therefore, for example, the various forms of cancers being positioned at below cervical region can be treated by more positive thermotherapy, and brain then maintains more normal core temperature simultaneously, or close to normal core temperature.

Therefore, according to each embodiment of the present invention, the method, system and equipment can provide the highest treatment temperature significantly improved, or the treatment time of significant prolongation, under making patient can be exposed to thermotherapy safely, lower the risk causing serious side effects simultaneously.More usefully, if core temperature keeps this temperature within quite long treatment time higher than 42 DEG C, and patient has no adverse effects, so thermotherapy just can more effectively be treated, and may cure as cancer, acquired immune deficiency syndrome (AIDS), hepatitis C and potential other diseases.In addition, if the core temperature that can realize at present, such as, lower than 42 DEG C, can maintain the longer time, thermotherapy also may be more effective.

More particularly, the treatment of carrying out inducing below cervical region thermotherapy to cancer or viral infection or chronic disease listed is in the past this method provided.By using the external heating of blood, water woollen blanket, radio frequency, infrared radiation, couveuse or any other heater, the core temperature of human body is improved.

It is preferred that the method includes by sending carotid artery blood to outside heat exchanger, instant heating cooling system, brain temperature is made to remain on a lower or normal temperature.This can realize by using an external pump, external pump extracts carotid artery blood, and then it is sent in a chiller, blood heat is adjusted to close to normal body temperature there, as 37 DEG C, and reinsert it in carotid artery second entrance closer to brain.In addition, arterial blood can be extracted out from the tremulous pulse of arm or leg, such as, by using external cooling system to cool it to a normal temperature, then refills it to internal carotid artery, thus makes the blood lower than thermotherapy treatment temperature flow to brain.

Owing to flowing cerebripetal blood heat lower than the temperature needed for the following thermotherapy treatment of cervical region, so in some embodiments, the blood returned from brain is entering heart through internal jugular vein, is preferably heated to a target temperature lower than the following body temperature of cervical region.Heating can come through second external bypath system by sending blood, makes it be heated to a target temperature.Bypath system may comprise and uses external pump to extract internal jugular vein blood, and blood is sent into heater, makes it reach target lower than the following core temperature of cervical region, and is reinserted in the internal jugular vein of second position below first position.In addition, also can the blood extracted out from internal jugular vein be reheated temperature required, then re-inject in the vein of arm or leg.

Although be arranged on the external heating system of internal jugular vein, fully can heat the core temperature of below patient's neck, but we also can provide how extra heater, as used hot water blanket, perception woollen blanket or be used in particular for the couveuse of inducing systemic thermotherapy, or other external heating device, their can also be re-injected in vein by heating blood, thus cause its health to be heated to target temperature, or adopt as the electromagnetic wave such as infrared ray or radio wave carrys out heatable body.

Under brain is maintained at lower or normal temperature, so usually when whole-body hyperthermia, the body temperature below cervical region can bring up to more than 42 DEG C, or choice for use extends the treatment time of whole-body hyperthermia.

Therefore, the system of this improvement, the body temp that equipment and method provide below extracorporeal blood treatment is set up and maintained when low temperature or Microwave cervical region is poor, keeps the brain of a relative normal temperature simultaneously.Particularly, while the risk reducing brain injury and other adverse effects of minimizing, thermotherapy treatment can use higher temperature, as more than 42 DEG C or higher and/or longer time, carrys out Therapeutic cancer, other diseases and medical conditions.

In the following detailed description and in conjunction with the accompanying drawing of the first-selected embodiment of the present invention, namely just illustrate, the present invention above-mentioned with other object, feature, aspect and advantage will become more obvious.

Accompanying drawing illustrates brief introduction:

Figure mono-is the major arteries of cervical region and brain, and the schematic diagram of their how branches;

Figure bis-is diagrams of this circulation of Willie, and how the arterial blood it illustrating cooling flows to each position of the brain usually supplied by ridge vertebral-basilar artery from internal carotid artery;

Figure tri-is high level diagram of first embodiment of the invention system, illustrates when all conduits are inserted into the tremulous pulse at cervical region or the vein of patient, how will the bypass circuit of cooling and heater be had to be connected to patient;

Figure tetra-is high level diagram of second embodiment of the invention system, illustrate when a conduit is inserted into carotid artery or the jugular vein of patient, when another conduit on same circuit is inserted in the tremulous pulse of arm or vein, the bypass circuit of cooling and heater how will be had to be connected to patient;

Figure five shows the schematic diagram of the equipment key part of the first embodiment of external chiller;

Figure six shows the schematic diagram of the equipment key part of the first embodiment of external heating device;

Figure seven shows the temperature curve of the key parameter when implementing the method for the present invention first preferred embodiment.The figure illustrates the temperature (brain temperature) of brain, by the core temperature of the jugular blood flow temperature of external heating device and patient;

Figure eight shows the heat transfer parameter (enforcement as figure seven) when implementing the method for the present invention first preferred embodiment.The figure illustrates and how will flow through the blood flow heating of internal jugular vein by external heating device, and how to be cooled flowing to carotid arterial blood by external chiller, and how heat loss is carried out to surrounding;

Figure nine shows the temperature curve of the key parameter when implementing the method for the present invention second preferred embodiment.The figure illustrates the temperature (brain temperature) of brain, by the core temperature of the jugular blood flow temperature of external heating device and patient, and flow to carotid arterial blood temperature by external chiller.Arterial blood is cooled to less than 37 DEG C in this embodiment, to guarantee the individual relative constant temperature of brain Wen Youyi;

Figure ten shows the heat transfer parameter when implementing the method for the present invention second preferred embodiment.The figure illustrates and how will flow through the blood flow heating of internal jugular vein by external heating device, how being cooled flowing to carotid arterial blood by external chiller, and how heat loss is carried out to surrounding;

Figure 11 shows the temperature curve of the key parameter when implementing the method for the present invention the 3rd preferred embodiment.The figure illustrates the temperature (brain temperature) of brain, by the core temperature of the jugular blood flow temperature of external heating device and patient, and flow to carotid arterial blood temperature by external chiller.Arterial blood is cooled to less than 37 DEG C in this embodiment, thus enhances cooling effect to brain.The temperature curve in two stages also can be used to the sensitive mechanism utilizing cooling suddenly;

Figure 12 shows the main heat transfer parameter when implementing the method for the present invention the 3rd preferred embodiment.The figure illustrates and how will flow through the blood flow heating of internal jugular vein by external heating device, how to be cooled flowing to carotid arterial blood by external chiller, and how heat loss is carried out to surrounding, how by infrared heating fluorescent tube, patient to be heated;

Figure 13 shows the temperature curve of the key parameter when implementing the method for the present invention the 4th preferred embodiment.The figure illustrates the temperature (brain temperature) of brain, by the core temperature of the jugular blood flow temperature of external heating device and patient, and flow to carotid arterial blood temperature by external chiller.Arterial blood is cooled to less than 37 DEG C in this embodiment, thus enhances cooling effect to brain.In addition, brain also can be cooled to below its normal temperature;

Figure 14 shows the main heat transfer parameter when implementing the method for the present invention the 4th preferred embodiment.The figure illustrates and how will flow through the blood flow heating of internal jugular vein by external heating device, how to be cooled flowing to carotid arterial blood by external chiller, and how heat loss is carried out to surrounding, how by infrared heating fluorescent tube, patient to be heated;

Figure 15 shows the temperature curve of the key parameter when implementing the method for the present invention the 5th preferred embodiment.The figure illustrates the temperature (brain temperature) of brain, the core temperature of patient, and flow to carotid arterial blood temperature by external chiller.Flow through jugular blood flow in this embodiment no longer by external heating device, therefore this blood flow temperature always followed by the temperature of brain with the temperature difference of negative 0.3 DEG C;

Figure 16 shows the major heat conduction parameter when implementing the method for the present invention the 5th preferred embodiment.The figure illustrates and how to be cooled flowing to carotid arterial blood by external chiller, how heat loss is carried out to surrounding, and how by tepidarium, patient to be heated;

Figure 17 shows the temperature curve of the key parameter when implementing the method for the present invention the 6th preferred embodiment.The figure illustrates the temperature (brain temperature) of brain, the core temperature of patient, and flow to carotid arterial blood temperature by external chiller.Flow through jugular blood flow in this embodiment and be cooled to the relatively low temperature of 30 DEG C.To the cooling of venous blood, preferentially help the cooling of heart and pulmonary, made, while these vitals of protection, the treatment of higher temperature can be taked;

Figure 18 shows the major heat conduction parameter when implementing the method for the present invention the 6th preferred embodiment.The figure illustrates and how to be cooled flowing to carotid arterial blood by external chiller, how heat loss is carried out to surrounding, and how by tepidarium, patient to be heated.The external chiller that a large amount of heats is attached to internal jugular vein is deleted, because this blood flow will be cooled to 30 DEG C;

Figure 19 shows the cross sectional representation of internal carotid artery and two 16 rule conduits, and shows this conduit and be inserted on this tremulous pulse with embodiment outer circulation circuit;

Figure 20 show extracted out by two 16 rule conduits have the blood of certain flow rate at the pressure of inlet wire and outlet, suppose that arterial pressure is 100 millimetress of mercury;

Figure 21 shows arterial pressure (cerebral) above delivery channel and intrinsic arterial pressure (arterial pressure) cross the volume of blood flow of extracorporeal bypass circuit functional relationship to pump;

Figure 22 shows and is fed to the blood flow of brain and the functional relationship by the blood flow of bypass circuit by internal carotid artery.The arterial blood flow direction that it also shows due to two conduits makes to enter the unexpected flex point of arterial blood Wen Youyi of chiller by inlet ducts on the contrary; With

Figure 23 shows the cross-sectional view of heat transfer block.

Detailed description of preferred embodiments

According to the preferred embodiments of the invention, native system, instruments and methods provides the temperature of other parts of independent regulation head or brain and health, core temperature below such cervical region can rise to is enough to disease therapy targetedly, maintain brain temperature close to normal temperature about 37 DEG C simultaneously, or maintain at least lower than the temperature of the following thermotherapy treatment of cervical region.

As by what be described in detail below, with reference to figure tri-, four, five and six, provide the thermotherapy of below cervical region according to the preferred embodiments of the invention native system and equipment, such as, come Therapeutic cancer or other infectious disease with this.

Thermotherapy below cervical region has been come by method below.Human body core temperature can by using extracorporeal blood heater, and hot water woollen blanket, couveuse, radio-frequency radiation, infrared radiation or any other heating instrument increase.Because brain is mainly cooled by cerebral blood flow, so the blood by internal carotid artery can be sent to external heat cooling system thus keep brain temperature lower than human body core temperature by it.It extracts carotid artery blood by using an external pump, send it to a chiller, carotid artery blood can be adjusted to 37 DEG C or lower than the thermotherapy treatment temperature below cervical region there, and the place of the carotid artery blood of cooling being taken out carotid artery blood is above inserted in carotid artery again.Vascular forceps or any other device, can be used for limit blood wholly or in part flows directly in carotid artery, but it is not absolutely necessary.In addition, blood can take out blood by using external pump at the lower limb of easily operation or the tremulous pulse place of arm, sends it by cooling system, and then re-injects in internal carotid artery.This will guarantee that the temperature of the arterial blood being fed to brain is lower than the core temperature below cervical region.

Specifically describing the method for the present embodiment, before system and equipment, explain the key concept of mannequin surface modeling, the relational term introducing head and cervical region blood circulation will be very useful, please refer to figure mono-and figure bis-.

mannequin surface modeling

If people consider human body while the generation conscientiously noting heat and heat transfer, we are just appreciated that why brain has been the organ that first upborne core temperature destroys.First, clear-headed adult brain consumes 20 percent of about human body gross energy, and brain only accounts for 2 percent of the whole weight of health.Under the situation of having a rest, neuronal cell needs the energy than many several thousand times of other cells.The power consumption of a single Central Nervous unit is about 0.5-4.0nW (nanowatt), and 300-2500 is doubly more than the average power consumption (1.6pW) of soma.The all energy used due to nerve metabolism are finally converted into heat, so neural activity answers simultaneous Thermal release.The heat that this metabolism discharges constantly consumes from cerebral tissue.If we further consider, large capsules of brain skull parcel, and the heat that its per unit weight consumes total flow more than many ten times average than health, so seeming seldom to have is not other chances being cooled brain by cerebral blood flow.Therefore, cerebral circulation, seemingly from brain to pulmonary and skin, then arrives the Main Means of external environment condition heat radiation.E.Kiyathin provides and well summarizes brain fever treatment [11] under physiology and pathological conditions, also provides good general introduction in-vivo measurement being flowed into the arterial blood temperature of brain and the venous blood temperature of outflow brain.

If we suppose most of heat of brain consumption consume by cerebral circulation, the basic preservation of application energy relations, we can expect to flow out the venous blood flow of brain by internal jugular vein, by higher than the blood heat being flowed into brain by carotid artery or vertebral artery.This principle can represent with following formula:

${\stackrel{\·}{Q}}_{\mathrm{brain}}=\stackrel{\·}{V}\·\mathrm{\ρ}\·c_p(T_{\mathrm{jugular}}-T_{\mathrm{arterial}})$

Wherein:

it is the heat consumed with watt brain represented.

it is the cerebral blood flow represented by milliliters/second.

ρ is the blood concentration represented with grams per milliliter.

C _pthe blood specific heat represented by joule/gram degree Celsius.

T _jugularby degree Celsius venous blood temperature being flowed out brain by jugular vein represented.

T _arterialit is the arterial blood temperature being flowed into brain by internal carotid artery or basilar artery.

Be in the steady-state condition of poised state at brain under, the heat produced by brain is transferred and is taken away by cerebral blood flow, and above-mentioned equation will be set up.If we use the numerical value of typical adult male in above-mentioned equilibrium relationships, and suppose the cardiac output of 5 liters/min, the cardiac output (16.6 milliliters/second) of 20% is then cerebral blood flow, and haemoconcentration ρ is 1.06 grams per milliliters, and supposes blood specific heat c _pbe 3.77 joule/gram degree Celsius, we find, the temperature difference that artery supply and vein flow out is about 0.3 DEG C.We measure people, draw the temperature difference [11] of the artery and vein blood of 0.3 DEG C, consistent with our calculating.Because brain produces heat, the major way of its heat radiation is by heat transfer to brain blood, and the temperature of brain innately can be higher than venous blood, and the temperature of venous blood can be higher than arterial blood.The temperature of arterial blood is approximately core temperature.

In addition, research worker is observed and is reported the thermograde of brain inside.The temperature (as Hippocampus) being positioned at brain rear portion reaches 1 DEG C lower than the temperature (i.e. veutro striatum, veutro tegmentum and hypothalamus) of brain front portion.The temperature be positioned in the middle part of brain then has its intermediate value, as thalamus and dorsal part striatum.Show the direct measurement of arterial blood temperature, it is always lower than the temperature of any brain structure.This means, the brain temperature being positioned at brain front portion can than arterial blood temperature or body temperature up to more than 1 DEG C.The hypothalamus of regulate body temperature is positioned at the front portion of human brain, therefore has maximum temperature, so can become the temperature set-point of human body.It is exactly that this part brain region is always very active and consume more energy that the higher temperature of brain front portion is partly due to a fact.Because brain temperature is higher than core temperature, so when core temperature because thermotherapy or heatstroke or sick and start to rise, brain normally first start the organ being subject to irreversible infringement.Therefore, if system can increase the core temperature of below cervical region, keep head in lower temperature or normal temperature, it can improve the treatment temperature that will reach or extend the treatment time that will reach simultaneously.

Sympathetic nervous system is attempted to maintain each position of health and is reached temperature needed for it.Centralised temperature set point is exactly the hypothalamus being positioned at brain front portion.The stability of temperature is maintained by various feedback mechanism by hypothalamus.Regulate the hypothalamus of body temp set point to present circadian rhythm and reset temperature spot once in a while due to infectious agent and endotoxin to a higher level.But during thermotherapy inductive treatment, hypothalamus maintains health at its predetermined set point by attempting.When thermotherapy starts, sympathetic nervous system will be reacted, to attempt to offset the temperature raised.Blood vessel can be expanded, and heart rate can rise, and by attempting to carry heat arrival body surface thus be depleted in environment, blood flow is increased.Often increase by 1 DEG C of heart beating per minute on average and can increase by 11.7 times.At 37 DEG C, have the typical adult under heart beating 70 per minute for one, his heart beating can be increased to 105 times and be increased to 140 times per minute 43 DEG C time per minute 40 DEG C time.Systolic blood pressure can increase, thus makes blood flow faster, but the minimizing of the blood drag reduction caused due to vasodilation and at high temperature blood viscosity and diastolic blood pressure is reduced.Because palpitating speed and blood pressure raise, thermotherapy is avoided at present in most heart patient.Breathing rate also can increase, and breathing shoals.Health is also attempted to be lowered the temperature by perspire, and this will cause dehydration and weightlessness, although continuous intake liquid.42.5 DEG C time, feedback mechanism quits work, and health presents degree of depth heatstroke symptom, specifically, lacks perspiration exactly, palpitates quickly, Cheyne-Stokes respiration, central nervous system dysfunction and loss of consciousness.Although heart beating is still continuing but respiratory arrest.The above-mentioned adverse effect of thermotherapy, can be eased by system of the present invention, because hypothalamus still maintains lower or normal temperature, and directly do not know, the core temperature below cervical region is added to desirable temperature.This makes patient can stand the thermotherapy treatment of longer time.

Therefore, according to the preferred embodiments of the invention, this system, equipment and method aim to provide two benefits.First, the core temperature below cervical region can be raised to a desirable treatment level, and keep brain a lower or relatively normal temperature simultaneously, thus reduce the ill effect to brain, this core temperature normally raised by one causes.Second benefit is exactly, because the hypothalamus that control sympathetic nervous system thermoregulation compensation mechanism remains on one close to normal temperature, therefore it can not directly be known, the temperature below cervical region is raised to more than design temperature, and therefore its thermoregulation compensation mechanism is suppressed.

head and neck blood circulation.

Before starting to describe the preferred embodiments of the invention in detail, importantly to understand the blood circulation of head and cervical region.Have two tremulous pulsies blood is transported to cervical region again by blood supply to brain.The most of blood of internal carotid artery supply in left and right needed for brain, other lesser amt required, is supplied by left and right vertebral artery.Carotid artery transports the vertebral artery blood of more than about 4 times.Equally, the most of blood flowed out from brain also can pass through cervical region, then through two veins, namely internal jugular vein and vertebral vein.Jugular vein carries most blood, and vertebral vein then carries the blood of lesser amt.Be positioned at the surface near cervical region in view of internal carotid artery and internal jugular vein and carry the outflow of about 80% or flow to the blood of brain, so be optimal to the outer bypass circuit of their embodiment, thus setting value that thermal conditioning brain Wen Youyi lower than the core temperature below cervical region.

Fig. 1 is the Arterial system schematic diagram of head and cervical region, which show the tremulous pulse that some are relevant to this discussion.It is also imperfect, and a just schematic diagram, which show its logic interconnection and internal carotid artery and the vertebral artery branch together with its Main Branches.Arterial system is from pulmonary artery, and it carries the blood from right ventricle of oxygen depletion to lung, and waste gas transforms there, and gets back to left ventricle.Then oxygenated blood fluid is pumped into aorta by left ventricle.Oxygenated blood fluid is transported to the aortal Main Branches-innominate artery of head and cervical region the most at last, and it leads to right clavicle tremulous pulse, left clavicle tremulous pulse and left common carotid artery.There are right common carotid artery and right vertebral artery in the branch of right clavicle.A left side, the origin of right carotid is different, and right common carotid artery originates from clavicle tremulous pulse left common carotid artery and then directly originates from aortic arch.Be exactly left vertebral artery below at left clavicle.

Carotid artery is divided into external carotid artery and internal carotid artery.External carotid artery and branch's supply blood thereof are to partial head and cervical region, but the blood part of those supplies is not the inside of supply skull, is not therefore the key regulating brain temperature.Internal carotid artery, from main total arterial branch out, directly enters skull through neck by carotid canal.Internal carotid artery in skull and branch's supply blood thereof are to brain.The Main Branches of internal carotid artery as shown in the figure.They are ophthalmic arterys, AChA, anterior cerebral artery, middle cerebral artery and posterior communicating artery.Due to the part that internal carotid artery is cooling bypass circuit, therefore, a temperature lower than neck lower body thermotherapy treatment temperature will be adjusted to by the blood of internal carotid artery and branch thereof.

the brain of the Main Branches of internal carotid artery and their supply any parts.

Anterior cerebral artery is that a pair supply oxygen is to the most frontal lobe of inboard portion and the tremulous pulse of upper inner side top.These two tremulous pulsies are parts of this circulation of Willie, and we will be discussed further below.

Middle cerebral artery is three couples mainly one of pairing tremulous pulse that brain is arrived in blood supply.It results from internal carotid artery, extends to lateral sulcus, and then branch comes the corticocerebral many places of supply side.It also provides blood to arrive front temporal lobe and narrow cortex.

Posterior communicating artery is one of the blood vessel on the right side of a pair and left side in this circulation of Willie.It connects the cerebral arteries of three the same sides.Front is a branch of internal carotid artery end three branch.Anterior cerebral artery and middle cerebral artery are other Liang Ge branches of three branches.Posterior cerebral artery is then linked up in rear.

Ophthalmic artery is a branch of internal carotid artery, its supply eye branch and other structure on eye socket.It enters eyeball by optic canal, and together with optic nerve.

AChA is a quite little tremulous pulse, is a branch of internal carotid artery.This artery supply choroid plexus, optic chiasma, capsula interna, lateral geniculate body, pallidum, caudatum, Hippocampus tail, corpus amygdaloideum, black substance, rubrum and crura cerebelli tumor.

Vertebral artery is stretched upwards by cervical region, is then branched off into spinal cord and muscle arteries.Once vertebral artery enters skull, just having multiple branch provides blood to brain and spinal cord.Lower cerebellum after being exactly specifically, oblongata, front spinal cord, rear spinal cord and meningeal arteries.Left and right vertebral artery is joined at skull bottom and is formed basilar artery.Branch out multiple small artery from basilar artery, be referred to as pon, be i.e. front lower cerebellar artery and rear cerebellar artery.

the brain region provided by vertebral artery and branch thereof.

Vertebrarterial meninges branch supply cerebellar falx.

From vertebral artery branch rear spinal artery out, finally enter a point arachnoid cavity, to supply Oxygenated blood to spinal cord.

The front portion of front spinal artery supply spinal cord.

Rear lower cerebellar artery is the maximum branch of vertebral artery, and it is three and is mainly one of tremulous pulse of cerebellum Nutrient artery blood.This arterial branch supply choroid plexus and ventriculus quartus.

Basilar artery are formed when left and right vertebral artery is joined.Basilar artery provide the rear portion of blood this circulation to Willie, and carotid artery provides the front portion of blood this circulation to Willie, then two bursts of blood flow mixing in this circulation of Willie.

The front lower cerebellar artery branched out from basilar artery supplies the top and bottom of cerebellum and little pons branch.

Then, basilar artery are divided into posterior cerebral artery and superior cerebellar artery.

Posterior cerebral artery is a pair supply oxygenated blood fluid to one of blood vessel of brain rear portion and occipital lobe.

The pinus of upper cerebellar artery supply ventriculus tertius, front marrow soft palate and chorioid tela.

Because hypothalamus controls the thermoregulation compensation mechanism of sympathetic nervous system, so consider to select which Arterial system supply oxygenated blood fluid to be very important to this key area.The hypothalamus of Semen Armeniacae Amarum size only accounts for the very little part of brain, and with hypophysis in same place.Wherein there are two artery supply oxygenated blood fluids to hypothalamus and hypophysis.Specifically, they are exactly upper hypophyseal artery and pendant tremulous pulse.Upper hypophyseal artery supply pars tuberalis, it is the funnel of hypophysis and median eminence.It is also a branch of internal carotid artery branch posterior communicating artery out from this circulation of Willie.Pendant tremulous pulse is the tremulous pulse of supply hypophysis.It is a branch of internal carotid artery.Importantly it should be noted that supply blood gives these two tremulous pulsies hypothalamic all from carotid artery instead of vertebral artery.Therefore, if carotid blood is passed through in our thermal conditioning, allow hotter blood flow through vertebral artery, cooler blood still can be sent to hypothalamus by us, therefore will reduce thermoregulation compensation mechanism, and its can occur when core temperature improves usually.

this circulation of Willie

To last link of cerebrovascular system, what we needed conscientiously to discuss is this circulation of Willie.This circulation of Willie links together internal carotid artery and vertebral artery/basilar artery system, is recycled to brain to provide sufficient or attached.Can find out in FIG, left, right carotid is branched off into their respective anterior cerebral arterys.These two anterior cerebral arterys connect by the anterior communicating artery.Therefore, the blood of the anterior communicating artery can arrive or from the region supplied by each internal carotid artery by left-to-right flowing, vice versa.Equally, basilar artery are branched off into posterior cerebral artery.Then, posterior cerebral artery is connected to respective internal carotid artery by posterior communicating artery.This makes blood usually flow from the region of vertebral artery/basilar artery or carotid artery supply by after forward direction, and vice versa.This circular chart of Willie can be seen in fig. 2.

Usually under normal operation, get clogged or damage when one of major arteries, this circulation of Willie will provide an extra approach.Such as, if vertebral artery gets clogged, so no longer can receive Oxygenated blood at the basilar artery of its top or end, therefore, a pressure drop will be had at basilar artery.And in Willie, the blood of this circulation will start from internal carotid artery, by posterior communicating artery, flows to and supplies posterior cerebral artery and basilar artery.

In this application, comparing with vertebral artery due to carotid artery is suitable epidermis (namely near body surface), so more easily implement carotid artery thermal bypass system.By increasing the pressure to internal carotid artery blood vessel, likely bring out cooler, the carotid artery blood be conditioned supplies brain region by this circulation of Willie, and those brain regions are normally supplied by vertebral artery and basilar artery.Therefore, although the bypath system of cooling arterial blood is only implemented on carotid artery, it will likely use the most brain of colder blood supply.

preferred embodiment

Now, we are by description two preferred embodiments, their difference is mainly the placement of conduit, and one or more circulation bypass circuits of connected system are carried out extracorporeal blood treatment by these conduits, thus provide regulation and control to the temperature of tremulous pulse or venous blood flow.In first preferred embodiment, all conduits are connected to the blood vessel (see Fig. 3) of neck area.In second preferred embodiment, a conduit is inserted into the blood vessel of cervical region, and second conduit of same circuit is then inserted into not too important arm, the blood vessel (see Fig. 4) of lower limb or trunk.

first preferred embodiment of the present invention:

First more detailed flow chart of preferred embodiment of the present invention can see Fig. 3.This is a parent map highlighting human blood circulatory system, and how downward for cervical region thermal therapy system is connected on human body by the bypass circuit of the first and second extracorporeal circulation of blood by display.Each bypass circuit comprises heat exchanger, and each heat exchanger comprises respective left chiller 400 and right chiller 600, left heater 500 and right heater 700.A control system 300 comprises a computer data acquiring/control module 117, more in addition respective heater 500 and 700, chiller 400 and 600, by data acquisition control bus 116, also comprises a suitable user interface.

Intravasation can use well-known Seldinger technology, and it is with the naming of Sweden radiologist Sven-Ivar doctor Seldinger.By one, required blood vessel is called that the sharp hollow needle of sleeve pipe punctures, if necessary, this process will be carried out under hyperacoustic guidance.Then, the seal wire of circle point is introduced into by the needle lumen of sleeve pipe, and sleeve pipe is recalled.Sheath or conduit can pass through seal wire intravasation.After sheath or conduit intravasation, seal wire is withdrawn.Seldinger technology is a kind of method of conventional introducing ductus arteriosus.Make in this way, ductus arteriosus can be inserted into the carotid artery of cervical region, or uses other method to be inserted into arm or lower limb, or on other suitable tremulous pulsies of trunk.

Fig. 3 shows how cooling and heater are connected to patient.In this is arranged, all arteries and venous duct are all connected to cervical region.Want keeping system flexible as much as possible and sufficient, we need to use independent heating and cooling device in the left and right sides.

Chiller 400 cools the blood travelled at RICA.The blood of RICA is extracted out by conduit, be connected to inlet wire 401, then chiller 400 is sent to, the temperature of blood is cooled to a target temperature such as 37 DEG C, after this by outlet 402, refill the RICA of blood to patient of cooling, just refill and be a little higher than said extracted point.Equally, chiller 600 cools the blood travelled at left internal carotid.The blood of left internal carotid is extracted out by conduit, be connected to inlet wire 601, then chiller 600 is sent to, the temperature of blood is cooled to a target temperature such as 37 DEG C, after this by outlet 602, refill the left side internal carotid artery of blood to patient of cooling, just refill and be a little higher than said extracted point.

Heater 500 heating returns the thermotherapy temperature of blood to treatment of right internal jugular vein, then just allows to mix it and other blood being core temperature.After the blood of right internal jugular vein is extracted by conduit, be connected to inlet wire 501, be admitted to heater 500 after this, be heated to required temperature there, to reach or to maintain the thermotherapy of patient, then by outlet 502, re-inject in the internal jugular vein of patient by blood by conduit, just refilling a little will lower than said extracted point.

Same, heater 700 heating returns the thermotherapy temperature of blood to treatment of left internal jugular vein, then just allows to mix it and other blood being core temperature.After the blood of left internal jugular vein is extracted by conduit, be connected to inlet wire 701, be admitted to heater 700 after this, be heated to required temperature there, to reach or to maintain the thermotherapy of patient, then by outlet 702, re-inject in the internal jugular vein of patient by blood by conduit, just refilling a little will lower than said extracted point.

Fig. 4 shows one and has the different abnormal type embodiment arranged, and wherein each extracorporeal circulation conduit is all on neck, is then inserted into the tremulous pulse on arm at other conduits of same circuit.The benefit of this set is, so not crowded on neck, reduces to minimum to the infringement of cervical region important blood vessels.

Warm arterial blood is extracted out by the tremulous pulse of conduit from arm, be connected to inlet wire 401, then chiller 400 is sent to, the temperature of blood is cooled to a target temperature such as 37 DEG C, after this by outlet 402, refill the RICA of blood to patient of cooling, so that the arterial blood of cooling returns brain and keeps its temperature close to 37 DEG C.

Same, chiller 600 cools the blood of the left internal carotid upwards flowed.Homoiothermy is extracted out by the tremulous pulse of conduit from arm, is connected to inlet wire 601, is then sent to chiller 600, be cooled to a target temperature there such as 37 DEG C, then by outlet 602, blood is re-injected into the left internal carotid of patient, allow the arterial blood of cooling get back to the brain of patient.

Heater 500 heats the right internal jugular vein blood that the flows downward thermotherapy temperature to treatment, then just allow mixing it with other blood being core temperature.After the blood of right internal jugular vein is extracted by conduit, be connected to inlet wire 501, be admitted to heater 500 after this, be heated to required temperature there, to reach or to maintain the thermotherapy of patient, then by outlet 502, blood is re-injected into the arm vein of patient.

Same, heater 700 heat the right internal jugular vein blood that the flows downward thermotherapy temperature to treatment, then just allows to mix it and be other blood of core temperature.After the blood of left internal jugular vein is extracted by conduit, be connected to inlet wire 701, be admitted to heater 700 after this, be heated to required temperature there, to reach or to maintain the thermotherapy of patient, then by outlet 702, blood is re-injected into the arm vein of patient.

Fig. 5 shows the detailed maps of the arterial blood chiller in the embodiment system of first and second.The object of this device is that the arterial blood of cool warm is to the sustainable temperature of brain, then refills arterial blood to internal carotid artery.A conduit is installed on tremulous pulse, and blood is drawn out of there, then connects the conduit to the inlet wire 101 using the medical tube of suitable size to make.Pump 104 extracts blood from inlet wire 101 by conduit.Although can use the pump of other types, first-selected pump is peristaltic pump.On inlet wire before pump, we have installed a temperature sensor 113 and pressure transducer 110.The object of these two sensors is the temperature and pressure weighing access ports blood.When entrance and exit tubes connection is on identical tremulous pulse, the temperature reading of temperature sensor 113 is presented at below core temperature, and this situation shows to create recirculation between outlet and entry conductor.One accurately inlet pressure reading be very important, it can guarantee that the blood pressure lowering of whole conduit does not exceed standard, otherwise will have potential blocking.A small amount of instrument is used to be placed on the import department of pump 104, to reduce the blood pressure lowering of pump suction side as far as possible.At the delivery outlet of pump 104, we have an effusion meter 105, and it is used to monitored volumes blood flow, and guarantee that enough circulations are by instrument.Ensuing is a pressure transducer 111, and it is used to measure the pressure on delivery side of pump.By the pressure reading between comparative pressure sensor 110 and 111, the direct reading that the pressure that we can obtain a pump 104 increases.Next device is exactly heat exchanger block 103 (i.e. heat exchanger).The object of heat transfer block is the transfer of heat of warm arterial blood to aseptic water-bath 106.Heat exchanger block 103 be designed with two targets.First be blood in heat transfer block should be the temperature closely equaling aseptic water-bath 106.As far as possible second target reduces the blood flow volume be trapped in heat transfer block, because this instrument does not need a large blood flow.It is the maximization being realized the heat-transfer area between blood and heat transfer block by a very wide but narrow rectangular channel, reduces the blood volume in heat transfer block simultaneously as far as possible.The outside of heat transfer block contacts with sterilization water-bath, and heat transfer block comprises many heat radiating fins, is as far as possible effectively transferred in metal derby by the heat in water.

Figure 23 depicts the cross-sectional view of the heat transfer block 117 of a suggestion.Heat transfer block 117 comprises two similar half parts, a left side renovate 120 and the right side renovate 121, define a clam shell design.Be external heat fins 123 in the outside of clam shell design, which increase work efficiency heat being transferred to heat transfer block 117 from water-bath 106.Two clam shell portion, are preferably designed to a rectangle greatly, narrow inner passage 122, and blood can be made thus to pass through.The design of this passage, decreases the blood volume needed for heat transfer block, thus makes required heat exchange more effective.This is obviously greater than its thickness by the width of design inner passage 122 to have come, and like this, the surface area being applicable to heat transfer is greater than the cross section of passage.In addition, a little thickness guarantees that most of blood of inner passage is in close proximity to heating surface.Optionally, inner heat fins 124 can design inner surface in inner passage 122 to improve heat transfer efficiency.A medical grade O shape circle grove 125 can make two clam shell portion keep sealing, and separable two parts clean.In operation, keep the pressure of inner passage 122 higher than the pressure of water-bath 106, make any potential leakage only can cause a small amount of blood bleeder, instead of potential pollutant are leaked in extracorporeal circuit device.

Stoping percolating water to enter in heat transfer block is by keeping the pressure of inner passage blood to come higher than the pressure of water-bath.The temperature of aseptic water-bath 106 is monitored by temperature sensor 115.Chiller 108 cools and carry out by cooling coil 107 cold-producing medium that circulates in aseptic water-bath 106, make aseptic water-bath maintain needed for temperature.The temperature of motor and impeller 109 recirculated water, to guarantee the even distribution of the temperature of whole bathtub.At the outlet side of heat exchanger, we have pressure transducer 112 and temperature sensor 114.Temperature sensor 114 is very important, because it provide the arterial blood temperature before re-injecting into internal carotid artery.Pressure transducer 112 provides the arteriotony of a direct measuring guide input, and gives the blood pressure lowering instruction of whole delivery channel.All temperature sensors, pressure transducer, effusion meter, pump, electric motor with vane wheel and refrigeration unit are linked together by data acquisition/control bus 116, so that they can by computer data acquiring/control module 117 Inspect and control.

Computer data acquiring/control module 117 has multiple use.The main purpose of the module 117 of control system 300 is to provide other key elements of monitor and forecast system, as temperature, and the adjustment of the key parameters such as flow velocity and whole system pressure.The temperature reading of various sensing point is used for controlled cooling model device, to guarantee that the temperature of aseptic water-bath obtains very strict regulation and control, thus guarantees the required arterial blood temperature at system outlet 102.Also controlled by the flow of peristaltic pump 104, to guarantee by the blood flow needed for this system.Because peristaltic pump is a kind of positive displacement pump, volume flow is directly proportional to the rotating speed of pump.The required flow that effusion meter 105 pairs of pumps provide provides verification.Multiple pressure sensor is mainly used in reporting to the police and detecting the situation whether system has blocking.If inlet pressure sensor 110 is lower than certain numerical value, this shows that inlet ducts causes the too large pressure drop to required blood flow.Further blood pressure lowering may cause the waste gas in blood to gather, and this is worthless, therefore carries out reporting to the police and informs that medical team reduces the rotating speed of air inlet and pump, to guarantee that pressure is not less than certain numerical value.Same, the necessary pressure being back to the desired blood of internal carotid artery by conduit is monitored at the pressure transducer 112 of system outlet.If pressure becomes too high, this may show catheter blockage, and can cause warning.If outlet pressure is too high, control module by reducing the rotating speed of pump, to guarantee to be no more than required numerical value.Extra pressure transducer can be used for the arterial pressure directly measuring internal carotid artery, and on the position being arranged on above-mentioned delivery channel, this arterial pressure will be the blood pressure entering brain.Pressure transducer may also be an independent equipment, is connected on control device 117.

There is provided highly stable temperature to regulate and just require that water-bath has enough thermal masses, to guarantee a relatively little rate of temperature change.The bathtub of one 20 liters needs 83.4 kilojoules to go to create the variations in temperature of 1 DEG C.With such bathtub, even if heat transfer block transmits the water of 500 watts, after 1 minute, bathwater only can experience the variations in temperature of 0.36 DEG C.This caloic comparative example control module provides the output that the sufficient time adjusts chiller 108, thus very strictly have adjusted bath temperature.In addition, break down thus make before too warm blood starts to flow to brain in patients at chiller, medical worker has a few minutes and goes to respond this situation.

Peristaltic pump 104 provides many advantages.First, it is a kind of positive displacement pump.This means, can be controlled easily, because it is directly proportional to the rotating speed of pump by the flow of equipment.Secondly, this pump is oneself's charging, and creates a suction on inlet wire, and blood is extracted into inlet wire.3rd, blood does not contact the machine components of pump, and is completely enclosed within sterilizing tube, and this sterilizing tube can be replaced sterilization easily between patient, decreases the risk of infection to greatest extent.

Fig. 6 describes the detailed diagram of a heater 200.Heater 200 is closely similar with the chiller 100 described in above-mentioned Fig. 5, except a few exceptions.At the inlet side of system, heater 200 receives the nice and cool venous blood by internal jugular vein returned from brain.Venous blood is extracted out from internal jugular vein by conduit, then delivers to inlet wire 101 by medical catheter.The object of heater is that heating blood arrives required temperature, and induction or maintenance thermotherapy, then logged off by outlet 102, then reinserted in vein by conduit.Go to cool aseptic water-bath relative to chiller and cooling coil, heater then has a power supply unit, and the electric power sent by heating element heater goes warm aseptic water-bath to reach required temperature.Except these exceptional cases, all very similar chiller mentioned above of sensor and control system.

the fluid machinery of the tremulous pulse outside embodiment or venous bypass circulation is considered:

How present let us discussion implements vascular bypass.We need to reach several target.First, we wish the outer bypass circuit of the blood flow embodiment of tremulous pulse or vein to regulate the blood heat by heater or chiller.Next, we wish the damage as far as possible reduced vein or tremulous pulse.3rd, need to reduce to change the pressure of cerebral arteries system as far as possible.

Pool Wa Zeyishi (Poiseuille) flow equation is well-known concerning those have the people of hydrodynamics background.This equation can by resembling such circulation pipes such as conduit or channel predicts fluid flow rate or blood pressure lowering rate.This equation needs other relations used when being applicable to Laminar Flow and becoming upheaval when flowing.

Pool Wa Zeyishi equation shows:

$h_{\mathrm{loss}}=\frac{128\·\mathrm{\μ}\·L\·\stackrel{\·}{V}}{\mathrm{\π}\·D^4\·\mathrm{\ρ}}$ Wherein

H _lossrepresent the blood pressure lowering by pipe.

μ is blood viscosity.

L is the length of pipe or conduit.

it is the blood flow rate by pipe or conduit.

π is well-known constant 3.14.

D is the inside diameter of pipe or conduit.

ρ is the density of blood.

Other the important fluid machinery parameters that should discuss are Reynolds that De Shi numbers.Your De Shi number of Reynolds is an immeasurable number, and the ratio which giving an internal force and viscous force is weighed, and has therefore quantized the relative importance of these two kinds of effects, thus is used for predicting whether liquid flow is Laminar Flow or turbulent flow.This is well-known concerning having the people of hydrodynamics background.Your the De Shi number of Reynolds moved at circular pipe or pipe flow is:

wherein V is the average speed of fluid in pipe, and μ is blood viscosity.Other variable is all being defined above.

Under normal circumstances, for the pipeline of circular section or the fluid flowing of pipe, R _eybe 2300 marks being used to predict that turbulent flow starts.As mentioned above, a pool watt damp ivady's formula is only applicable to laminar flow, is therefore only applicable to R _eybe less than the situation of 2300.When upheaval, need to calculate blood pressure lowering by conduit or pipe by empirical equation, instead of with pool watt damp ivady's formula.

In our application process, be approximately 400 ml/min by the typical rate of internal carotid artery or internal jugular vein blood flow.Normal blood viscosity is about 3 times that are greater than water, but along with different temperature and individual body constitution, particularly cell backlog and change.To some individual, blood viscosity can up to 10 of water times.And our calculating, be μ=3.26x10 by the representative value of a hypothesis blood viscosity ^-3pa*s.

For flow velocity and the μ=3.26x10 of 400 ml/min ^-3the blood viscosity of Pa*s, inside diameter is the conduit R of 1.2mm _eyto be 2300.Conduit size rule coming measures, and 1 rule equal 1 inch of external diameter divided by conduit.Typical vein or ductus arteriosus have size 12 to advise, 14 rule and 16 rule, and its external diameter is just respectively 2.11 millimeters like this, 1.81 millimeters, and 1.587 millimeters.Under normal circumstances, internal diameter is about 0.3 millimeter, is less than external diameter, and therefore the inside diameter of the conduit of 12,14 and 16 rule is respectively 1.81,1.51 and 1.29 millimeters.For the conduit of these sizes, suppose above-mentioned flow velocity and blood viscosity, R _eyto be 1530,1830 and 2140 respectively.So even if the 16 rule conduits that relatively little, flowing also will be laminar flow.

The Fenwal heavy caliber pipe (Fenwal Large Bore Tubing) that the DelmedY type blood of an inside diameter 3.0 millimeters dissolves that pipe box dress (Delmed Y-Blood Solution Set) and inside diameter are 3.66 millimeters for transmitting two kinds of medical catheters of blood.For above flow and viscosity, consequent R _eywill be respectively 920 and 754, they are by the starting point well below turbulent flow.

Figure 19 depicts the schematic diagram that two conduits 301 and 302 are inserted into internal carotid artery 304.The object of this figure is, in order to provide a sample to calculate to us, namely how to calculate by the flow velocity of chiller 100 arterial pressure affecting internal carotid artery, and how to calculate the pressure of assessment in each profit point.First conduit 302, entering inlet wire 101 for extracting blood from tremulous pulse out, being then sent to chiller 100.Second conduit 301, for receiving the colder blood refluxed from chiller 100, and reinsert it to internal carotid artery, be cooled to the blood of lower temperature to brain to supply, the thermotherapy treatment temperature below the cervical region that this temperature is experiencing than patient is much lower.

Under normal circumstances, let us hypothesis patient has a normal arteriotony, i.e. the systolic pressure of 120 millimetress of mercury and the diastolic pressure of 80 millimetress of mercury.Then let us calculates the flow velocity of 400 ml/min discussed above by carotid pressure, and when we use full flow (400 ml/min) by pressure during chiller.Therefore, for the conduit of one 16 rule, 4cm is long, inside diameter 1.29 millimeters, and we expect to see due to viscosity loss, is 13.2 kPas (pool Wa Zeyishi equations) by the blood pressure lowering of conduit.In addition, due to the result of sudden contraction, it is the pressure loss that the conduit of 1.29 millimeters seems to experience other 10.7 kPas that blood flow is transformed into inside diameter from the carotid artery that diameter is 3mm.The pressure loss that this precipitate discontinuity causes normally utilizes empirical equation to calculate.As a result, in order to be drawn onto with the flow velocity of 400 ml/min in the conduit of one 16 rule by blood, the pressure of inlet wire 101 and inlet wire and conduit meet the pressure in place must at about 24 kPas, and it is lower than carotid arterial pressure.This will cause the negative gauge pressure of inlet wire, and about-10.7 kPas (relative to atmospheric pressure) or 90.6 kPas (absolute pressure), suppose that the average pressure of tremulous pulse is about 100mmHg.Because the absolute pressure of 90.6 kPas is far away higher than the vapour pressure of blood, so system should be had no problem keep this flow velocity.Along with core temperature is increased to more than 37 DEG C, blood viscosity can decline to a great extent, and this will make the blood of extraction much easier by conduit.The pressure thinking over inlet wire is very important, because when the vapour pressure of pressure close to blood, this just represents a strict restriction, exceedes this and limits us and just do not extract extra blood out by conduit, therefore preferably uses a larger conduit to sentence minimizing blood pressure lowering entering blood.The flow velocity of flow velocity 400 ml/min, we should use the conduit of 16 rule and use a positive-displacement pump, and we use in systems in which similar.Medical catheter, is exactly the conduit for inlet wire 101, should has enough rigidity, so that it can not collapse because of the result of the negative gauge pressure on this circuit.

Equally, enter tremulous pulse in order to promote blood by conduit, the pressure of egress line 102 should be much higher than carotid artery pressure.Because we still use 16 rule conduits, we can run into the pressure drop of 12.8 kPas that cause due to viscosity loss again.In addition, due to discontinuity sharply, namely when from the conduit that inside diameter is 1.29 millimeters, to be transformed into inside diameter be the carotid artery of 3 millimeters to blood flow, blood flow will experience the pressure loss of 13.2 kPas.Final as a result, at the pressure of egress line 102, must more than carotid artery pressure about 26 kPas.Within the scope of this, the malleation of appropriateness has not been subject matter, because most of medical catheter can bear this pressure.

To be closely similar to jugular analysis.Since our target is flow velocity identical on jugular vein, and above-mentioned viewed with us by the blood pressure lowering of import and delivery channel, will be closely similar.A crucial difference is that the pressure of jugular vein blood vessel is considerably low, is about 10 millimetress of mercury (generally, depending on that patient stands or recumbency).Therefore, will be lower in the pressure gauge pressure of inlet wire, be about-22.6 kPas (relative to atmospheric pressure), or the absolute pressure of 78.6 kPas.So suppose that we use the conduit of same size, use by the flowing equal with tremulous pulse circuit of vein circuit, first we will reach the vapour pressure of blood on vein circuit.Therefore, in some cases, slightly large conduit is used may to be useful in vein import department.

Present let us is looked at a more great-hearted system and is evaluated when we change and control the blood rate by tremulous pulse chiller 100, and how cerebral artery pressure changes.As previously mentioned, because chiller 100 and heater 200 use a positive discharge capacity peristaltic pump, so can be controlled easily, because it is directly proportional to the rotating speed of pump by the flow velocity of bypass circuit.Therefore, we by increasing the rotary speed of pump, thus can increase the blood flow volume by bypass circuit, as long as the blood pressure at system inlets place is not less than steam pressure by us.Along with we send, increasing blood is by bypass circuit in present let us analysis, and how about Blood pressure of carotid artery will change.Figure 20,21 and 22 is results that this is tested.

The pressure that Figure 20 shows inlet wire 101 and outlet 102 with by driving by a kind of functional relationship of the blood flow of chiller 100 or heater 200.In this is analyzed, we suppose that the mean arterial pressure of internal carotid artery is 100 millimetress of mercury (relative to atmospheric pressure).At first, because the bypass blood flow of 0 ml/min does not have any pressure drop by inlet wire conduit, therefore, the pressure of inlet wire equals the arteriotony of 100 millimetress of mercury (relative to atmospheric pressure).In outlet, because these two are inserted into carotid conduit, part blocks blood flow, make by carotid pressure drop, blood flow is about 320 ml/min, thus the pressure of inlet wire is equal to mean arterial pressure, is 80.1 millimetress of mercury.If say and be increased to 400 ml/min by the blood flow of bypath system, so will have a larger pressure drop by conduit, the pressure of inlet wire 101 and outlet 102 will drop to-80 millimetress of mercury (relative to atmospheric pressure) and 280 millimetress of mercury (relative to atmospheric pressure) respectively.Along with the Hemodynamic environment by bypass resistance is increased to 600 ml/min further, the pressure of whole conduit reduces and also can again increase, and the pressure of present inlet wire 101 and outlet 102 becomes-170 millimetress of mercury (relative to atmospheric pressure) and 380 millimetress of mercury (relative to atmospheric pressure) respectively.

Figure 21 shows mean arterial pressure, and after bypass blood flow is reinserted into tremulous pulse, carotid artery is supplied to the arterial pressure of brain.The top of the corresponding Figure 19 in position, and got the printed words of " exit criteria ".These pressure have been shown and the relation being heated or cooled the blood flow that bypass circuit drives.Do not have the insertion of conduit, whole carotid blood pressure lowering will be very little, and cerebral will no better than arterial pressure.Due to the insertion of two conduits, carotid cross section is partly reduced, and result is whole carotid artery thereby produces about 20 millimetress of mercury blood pressure lowering at the tip of two conduits.The blood pressure lowering of this 20 millimetres of mercury is also applicable to when not having blood flow by bypass circuit.Gradually, when the blood flow by bypass circuit is increased to 400 ml/min (by the carotid original flow velocity of patient), at the original value of pressure recover to 100 millimetress of mercury arriving brain in schematic diagram exit.Finally, along with the increase by bypass circuit blood flow has surmounted 400 original ml/min, the pressure to brain starts to be increased to and has surmounted original arterial pressure.By doing like this, we can increase the arterial pressure of internal carotid artery, and compared with vertebral artery/basilar artery, this forces blood earlier to flow through this circulation of Weir, as the discussion before us.When the blood that we send 600 ml/min is by bypath system, the mean arterial pressure in schematic diagram exit has been increased to about 110 millimetress of mercury, and comparing original value is then 100 millimetress of mercury.This represent mean arterial pressure and add 10%.If increase the blood flow by bypass circuit further, or the inner conduit between import and delivery channel tip increases the resistance of blood flow, and pressure may be increased to the level exceeding 10%.This can pass through on internal carotid artery, apply pressure and realize, if or use two soft palate conduit, the outer sleeve of conduit by demi-inflation (resembling in foley's tube), thus partly can limit blood flow further.

Figure 22 depicts the volume blood flow of carotid artery supply brain, and the blood flow rate directly flowing to internal carotid artery between import and delivery channel tip.At first, when blood flow is 0 ml/min by the flow velocity of bypass circuit, all cerebral blood supply have necessarily directly flowed to internal carotid artery, and the total blood flow being delivered to brain is 320 ml/min.Be 400 ml/min inserting the blood flow flowing to brain by tremulous pulse before conduit.The minimizing of this blood flow is conduit local stoppages because tremulous pulse is inserted into and resistance is increased.Owing to being re-injected into the increase of the blood flow rate of tremulous pulse by delivery channel by bypass circuit, the blood flow volume flowing directly into tremulous pulse starts to decline.Along with the blood flow volume flowing through bypath system reaches the original value of 400 ml/min, no longer include any blood and flow directly into internal carotid artery between two catheter tips.When reaching such condition, we are by whole blood significantly by heating or chiller, and such bypass thermotherapy can work effectively.From the angle of brain, we have got back to again original state, namely insert the state before conduit.Mean arterial pressure is 100 millimetress of mercury again, and the cerebral blood flow of this tremulous pulse is also 400 ml/min again.

Along with the blood flow volume by bypath system is increased to more than 400 ml/min by we, we start the blood flow reverse flow seen between two conduits.Because carotid artery is blocked by conduit portion, so when blood flow starts reverse flow, compare the pressure of Figure 19 entrance side 303, the pressure of Figure 19 outlet side 304 is bound to increase, thus drives blood flow.Gradually, along with the blood flow by bypass circuit is increased to 600 ml/min, flow cerebripetal cerebral blood flow and be increased to 440 ml/min.The blood flow increased mainly is pushed through this circulation of Willie, and supplies many brain regions, and this is normally provided by vertebra/basilar artery.

Want the reverse flow seeing blood, can by detecting the unexpected change of inlet wire blood heat.Such as, flowing into the artery blood flow of inlet wire 101, will be the core temperature 42 DEG C of patient's thermotherapy, as long as no the reverse flow of blood flow.Once we start the reverse flow seeing blood flow, the blood flow of inlet wire 101 will be flow to carotid artery and have the blood flow of thermotherapy temperature and between export and import conduit, carry out the combination that reverse flow has also been cooled to the blood of 37 DEG C.Can see in fig. 22, along with blood flow starts reverse flow, inlet temperature curve will have a very unexpected change.Advantageously, this phenomenon can be balanced by the control algolithm of system.

other embodiment

Although specific embodiment is described in detail above, we still advocate other arrangements in using the difference of these embodiments, to realize the different temperature difference under neck, such as, arrive the thermotherapy of brain or the low temperature therapy of brain.

In above-described embodiment refrigeration and heat bypass circuit by left and right carotid artery and internal jugular vein blood flow provide.Other arrangements for the heat exchanger of heating and cooling in these bypass circuits can be used.Optionally other positions of body cooling, as thermo-responsive tissue, also may be required, we will describe it now.

Above-described embodiment of the present invention have advantageously comprised thermal conditioning head or brain, and independent of other position of health, core temperature below such cervical region can be effectively increased, with targetedly disease therapy, keep brain temperature close to the core temperature of human normal simultaneously, be about 37 DEG C, or at least lower than the thermotherapy treatment temperature below the ongoing cervical region of health.When inducing thermotherapy treatment cancer or other infection states of below cervical region, the core temperature of health also can by using one or more extracorporeal blood heater, water blanket, couveuse, radio-frequency radiation or infrared radiation, tepidarium, or any other heating mechanism increases.

As mentioned above, the following thermotherapy of cervical region, because brain is mainly cooled by cerebral blood flow, so, flow through internal carotid artery or common carotid blood through an outside cooling system by sending, brain can maintain a temperature lower than body core body temperature.It can extract carotid blood out by use external pump, send it through apparatus for supercooling, there temperature is adjusted to 37 DEG C, or be adjusted to the temperature lower than cervical region following thermotherapy treatment temperature, and then reinserting in carotid artery, insertion point is higher than extraction point.Vascular forceps or foley's tube, the application of pressure or anyly can limit blood flow directly into other equipment carotid and can be used wholly or in part, but it is not absolutely necessary.In addition, the blood extracted out from tremulous pulse from exposed to contact position as lower limb or arm take out, can use external pump, sends it by a cooling system, then re-inject in carotid artery.This will guarantee that the arterial blood temperature being fed to brain is lower than the core temperature below cervical region.

If carotid vascular pressure can keep slightly higher than vertebrarterial vascular pressure, so cold-blooded will flow through Willie this circulation, namely from internal carotid artery to basilar artery and vertebral artery and their respective branches, thus the major part of cooling brain, and keep brain temperature lower than the body temp below the cervical region being subject to thermotherapy treatment.

The internal jugular vein blood turning back to heart from brain will be lower than thermotherapy treatment temperature neck.Therefore, the nice and cool blood that it must be heated or flow through internal jugular vein downwards will have a radiating effect to core temperature.If we rely on the external heating system of internal jugular vein as the main method of induction thermotherapy, so blood then must be heated to the temperature slightly higher than target thermotherapy temperature to compensate heat loss.If use other heating means, so blood only needs to be heated and enough arrives to prevent sub-cooled.Blood heat can realize to heating system by using external pump from internal jugular vein extraction blood and sending blood.Bypass circuit will comprise use external pump and extract blood out from jugular vein, blood will be sent to a heater, make it reach target temperature, and again be inserted in an internal jugular vein below vascular forceps.Or, external pump can be used to extract blood out from internal jugular vein, be heated to target temperature, and re-inject into a position being easier to contact, as one of the mainline of arm or leg.

Although the external heating system be arranged on jugular vein enough should heat patient to target temperature and the following core temperature of cervical region, if necessary, extra heating also can be provided, and such as, uses one or more

Hot water woollen blanket, perceptual woollen blanket or couveuse, these are normally used to bring out whole-body hyperthermia.

An external heating device, also again can be injected in vein by heating blood, thus causes health to be heated to target temperature.

Use electromagnetic wave, as infrared ray or radio wave carry out heatable body.

Namely the temperature be maintained at close to room temperature due to brain is about 37 DEG C, or maintains a lower temperature, so the downward body temperature of cervical region can be raised to more than 42 degree Celsius, and this temperature is normally used for whole-body hyperthermia.Can be kept below cervical region up to the higher temperature of 45 degree or potential Celsius, and such high temperature perhaps can Therapeutic cancer and animal infectious diease enough effectively, as acquired immune deficiency syndrome (AIDS), the disease of chronic inflammatory disease, as ulcerative colitis and Crohn disease, rheumatism, bronchial asthma, chronic and recurrent viral infection, even needs the disease of detoxifying.

In addition, because brain is maintained at more normal temperature, hypothalamus directly can not recognize that cervical region is raised with the core temperature of lower body, and therefore thermoregulation compensation mechanism will reduce.

other points for attention

Under brain is maintained at a relatively normal temperature, which type of other mechanism not clear will the adaptive capacity that raises the following core temperature of cervical region of restriction human body at present.Known to inventor, in the experiment of every other report, the temperature of brain always rises along with other positions of health, and therefore brain creates as increased heart rate, and breathe and accelerate, the reactions such as perspiration, because it attempts to prevent health overheated.Use its system and method according to embodiment of the present invention, under brain can be maintained at a normal temperature, cervical region is exposed at elevated temperatures with the remainder of lower body simultaneously.

the supplement heat rejecter of its hetero-organization

But the tissue cell insult be exposed at high temperature is a problem merited attention.Along with the following core temperature of cervical region is added to more than 45 DEG C and 45 DEG C, vertebra, lung and testis will be that the next one may impaired element.The infringement of these organs may be reversible, and they during restoration may recover oneself again.Otherwise they can be preferentially cooled and maintain a temperature lower than the treatment temperature of " the following core temperature of cervical region ".

Spinal cord: by directly contacting with backbone, ice bag is tightly attached to back, and spinal column can be cooled to the required temperature lower than the following thermotherapy treatment of cervical region.The experiment of local thermotherapy shows, a temperature difference (heat or cold) being applied in skin surface can penetrate into human body about 2 centimetres.In the experiment of local thermotherapy, thermal source is about 45 DEG C usually; Only high than normal body temperature 8 degrees Celsius, thermograde show permeable enter human body about 2 centimetres.The ability of cooling spinal column should be more favourable a little to thermotherapy, because cold compress can be low to moderate 0 DEG C, therefore the temperature difference of ice bag and thermotherapy treatment should be greater than 40 DEG C.

Testis: testis is that human body is to heat sensitive another one organ.In view of their position, keep testis temperature should be quite simple a little less than cervical region following core thermotherapy treatment temperature.Can by ice bag cold compress at treatments period testis, or around scrotum, the sack of certain form additional makes testis may be immersed in potentially in cold liquid.

Lungs: lung cells also may to sensitive.The potential means of preferential cooling one of pulmonary are exactly the air making patient respiration cold.Can be supplied to patient respiration far below the air of freezing point, this advantageously should cool pulmonary, compares the remainder of health, and the temperature of pulmonary can be low.Patient breathes by forced air delivery system, and the air of there is cooled to required temperature.Be low to moderate-20 DEG C or even the air of-30 DEG C can be had no adverse effects by sucking for a long time.Cold air should enter alveolar depths at such temperatures, and anti-Hemostatic Oral Liquid/air curtain is broken.

To lung, the preferential cooling of testis and spinal cord will make the remainder of health have heat loss.Therefore, if the target thermotherapy treatment temperature that cervical region will be kept downwards required, needs are added in body by extra heat, to overcome this heat loss.Extra heat adds, one of several method discussed above can using.

Experimental system:

According to advantageous embodiments of the present invention, below experiment depicts six analogy methods, and illustrating the following thermal therapy system of cervical region to people can how for clinical treatment patient.

Experiment A is a system implementation the simplest, its chiller be used on each internal carotid artery goes to cool the arterial blood of going to brain, the heater be combined on each internal jugular vein goes to heat the venous blood turning back to trunk, thus the thermotherapy state below induction cervical region.

Experiment category-B is like above-mentioned A, and just chiller is for cooling the arterial blood of internal carotid artery, and under the temperature controlling brain in this way remains on a stationary temperature.

Experiment C uses infrared illumination as an extra heating system, is rapidly heated to produce one.In addition, patient is exposed to two temperature plateaus, and first ratio second is warm, thus benefits from the sensitization that temperature reduces suddenly.Heater on infrared lamp and jugular vein is used for heating patient to required temperature.Control for the controlled circulation of chiller of cool stream to the arterial blood of internal carotid artery, be intended to keep the constant of brain temperature.

Experiment D is except a similar above-mentioned experiment C of exception.The temperature of brain is adjusted to one slightly lower than the temperature of normal value, causes patient to feel a bit cold, although core temperature is enhanced.

Experiment E uses tepidarium, and rapidly heating patient is to the quite high core temperature of 46 DEG C.Chiller is installed on internal carotid artery to maintain brain in a relatively cool temperature.Do not have heater to be installed on internal jugular vein, because do not have the cooling effect of heater to compare, the coefficient of overall heat transmission that tepidarium causes is very little.

Experiment F is except two similar experiment E of exception.First, the temperature of brain is adjusted to a temperature lower than normal temperature, thus has protective effect to brain.Secondly, chiller is installed on internal jugular vein, instead of heater.Chiller significantly reduces the venous blood temperature being back to heart, thus makes heart and pulmonary experience cooler temperature, under the major part of health is then exposed to very high thermotherapy temperature.

A more detailed description of each experiment is as follows:

Experiment A:

This most simply arranges, we use the chiller of tremulous pulse, feel nice and cool to keep the arterial blood flowing to internal carotid artery, simultaneously the blood of our internal jugular vein that uses heating devices heat to flow downward is to a necessary temperature, to heat the downward health of cervical region, thus induction thermotherapy, and reach certain therapeutical effect.Goal treatment temperature is about 42 DEG C.

Operation system setting:

Tremulous pulse chiller will be installed in a left side, and on RICA, to keep brain at cooler temperature, it is low that this brain temperature compares the thermotherapy temperature that patient will contact below cervical region.

The arterial pressure of internal carotid artery slightly will increase than the normal arteriotony of patient, is beneficial to blood and flows through carotid artery, instead of original vertebra/basilar artery.

In this case, the blood flowing to internal carotid artery will be adjusted to the temperature of about 37 DEG C.Heater is installed on internal jugular vein.

Heater is by the temperature of the warm blood flowing to internal jugular vein downwards to about 43 DEG C.

Extra thermal source is not had to be used.Patient will be allowed to be heated to one and reach thermally equilibrated temperature, and keep this treatment temperature levels about 24 hours.After 24 hours, will be stopped by the blood flow of heater, patient will be allowed to decline and fall back to normal temperature.In whole cooling procedure, continuation regulation and control are flowed the cerebripetal arterial blood by internal jugular vein, to guarantee the sensation that patient keeps comfortable by chiller.

The body temperature of patient will be monitored nearly in whole process.If patient is insulation, so his basal metabolism may exceed his heat loss rate to environment, and in this, when the venous blood temperature of the internal jugular vein being injected into him is 43 DEG C, and his core temperature may rise to more than 43 DEG C.If the body temperature of patient rises to higher than target temperature, woollen blanket should be taken away from patient, and to increase its heat loss rate to environment, like this, the core temperature that his cervical region is downward will fall after rise to target temperature.Equally, if the core temperature of patient is still lower than target temperature, so his heat loss rate to environment should be reduced, and this can realize by adding the insulators such as woollen blanket.

Experimental result and discussion:

The temperature curve of patient as shown in Figure 7.As t=0, bypass circuit is installed on internal jugular vein and internal carotid artery.In about 5 hours, the core temperature of patient can rise to about 41.7 DEG C from 37 DEG C, and after several hours, finally reach the equilibrium temperature of 41.9 DEG C, and keeps this temperature at treatments period.Brain temperature can a little more than initial temperature 37.6 DEG C, is the highlyest elevated to 38.1 DEG C.Although flow to a small amount of increase that vertebrarterial warm arterial blood causes brain temperature, most artery blood flow is adjusted to 37 DEG C, so brain temperature is more nice and cool to the temperature of internal carotid artery and this part blood.In future, flow to vertebrarterial warm blood although have, the blood heat flowing to internal carotid artery still can be adjusted to slightly lower than 37 DEG C by we, and like this, the bulk temperature of brain will keep at normal temperatures.In whole 24 hours, the blood heat flowing to internal jugular vein is adjusted to 43 DEG C by heater.

The lifting of patient temperature can adopt basic protecting energy principle to calculate:

T _Core＝Q _total/(m·c _p)

Here:

Q _totaltotal amount of heat in=patient body, relative to reference temperature.

The body weight of patient m=.

Avergae specific heat in CP=patient body.

$Q_{\mathrm{total}}={\∫\stackrel{\·}{Q}}_{\mathrm{environment}}\mathrm{dt}+\∫{\stackrel{\·}{Q}}_{\mathrm{Carotid}}\mathrm{dt}+{\∫\stackrel{\·}{Q}}_{\mathrm{Jugular}}\mathrm{dt}+{\∫\stackrel{\·}{Q}}_{\mathrm{BasalMetabolism}}\mathrm{dt}$

Wherein, Section 1 is the heat absorption/loss rate to environment, Section 2 comes from heat interpolation/clearance rate that the tremulous pulse chiller be arranged on carotid artery brings, Section 3 comes from heat interpolation/clearance rate that the heater be arranged on the jugular vein of patient brings, and last is the heat rate produced from the basal metabolism of patient oneself.All these parameters are with watt to measure, and they are along with the change joule of time is to calculate energy total value.If these sum total is positive number, As time goes on so hot total amount will increase, and patient will feel the increase of his or her core temperature.On the contrary, if these sum total is negative, As time goes on so hot total amount will reduce, and the core temperature of patient will decline gradually.

The heat added by heater and chiller or remove can be similar to as follows respectively:

${\stackrel{\·}{Q}}_{\mathrm{Carotid}}=\stackrel{\·}{V}\·{\mathrm{\ρ}}_{\mathrm{blood}}\·c_{p\_\mathrm{blood}}(T_{\mathrm{Carotid}}-T_{\mathrm{Core}})$

Here:

it is the blood flow volume flowing through instrument represented by milliliters/second.

ρ _bloodit is the density of blood represented with grams per milliliter.

C _{p_blood}the specific heat of the blood represented with J/gK.

T _jugularbe again be expelled to patient's vein before, through heater regulate venous blood temperature.

T _carotidbe again be expelled to patient's internal carotid artery before, through apparatus for supercooling regulate arterial blood temperature.

T _cerebral-0.3 DEG C be by heater before the venous blood temperature at internal jugular vein returned from brain.The temperature that this temperature is approximately brain by us deducts 0.3 DEG C.

T _corethe core temperature from the downward patient of cervical region, i.e. effective thermotherapy treatment temperature.The blood flowing to internal carotid artery from heart is assumed that the core temperature that about cervical region is downward.

The all heat transfer parameters relevant to this experiment can be seen in fig. 8.Positive number shows that heat is added to patient, and negative shows that heat is deleted from patient with it.As t=0, the heat more than 400 watts obtained from heater is added to patient, and does not have heat deleted from the chiller of tremulous pulse.This just makes the heater of vein by the blood being about 37.3 DEG C of a reception suitable normal temperature, and heats it to 43 DEG C.On the contrary, by receiving the arterial blood of current core temperature 37 DEG C, because 37 DEG C is the temperature of requirement, thus can not there is heat and deleting in the chiller of tremulous pulse.Gradually, along with the increase of the core temperature of patient, eparterial chiller starts the heat deleted in blood.When hygral equilibrium realizes, the heat summation of all interpolations and deletion should equal zero.

Experiment B:

This experiment experiment with former except a main distinction is identical.Here, we wish to keep the constant of brain temperature.Therefore, the design temperature of carotid artery blood chiller allows change.The design temperature of chiller is controlled in a circulation, based on the temperature of the venous blood returned from brain.Our target keeps the mean temperature of brain constant in 37.6 DEG C, and this is about as much as the temperature 37.3 DEG C of the venous blood returned from brain.If the temperature flowing to the venous blood of internal jugular vein returned from brain is more than 37.3 DEG C (before heater), so, controlled circulation will be implemented, and then the design temperature of carotid artery blood chiller will decline 0.02 DEG C.Turnover rate is every 2 minutes.Otherwise if when the temperature of venous blood is lower than 37.3 DEG C, so the design temperature of carotid artery blood chiller will rise 0.02 DEG C.This is a very simple control system, but due to slowly rate temperature change, it can very accurately follow the tracks of and keep the temperature constant of brain at 37.6 DEG C.

Fig. 9 shows the key temperatures relevant to this experiment.In former experiment, carotid artery blood heat is adjusted to 37 DEG C in whole process, and the temperature of brain is added to 38.09 DEG C from 37.6 DEG C (initial temperature of core temperature is 37 DEG C), and core temperature finally then reaches 41.9 DEG C.The slightly increase of brain temperature is the result owing to flowing to vertebrarterial warm arterial blood.But in the process, carotid artery blood heat is gradually adjusted a lower temperature 36.45 DEG C, thus causes brain mean temperature to be 37.6 DEG C, when core temperature has risen to 41.9 DEG C be also even.From hypothalamic angle, the body temperature of patient keeps relative constant in whole process always.

Interesting consideration is, if by regulating the temperature that flows to carotid arterial blood to a slightly low temperature, patient may be made to feel cold and wish to keep warm, although the core temperature in fact below his cervical region has been significantly higher than Normal Kernel body temperature 37 DEG C.If maybe when carrying out human trial, regulating temperature to a lower slightly temperature, patient can be made in whole hyperthermia process to feel more comfortable.

Figure 10 shows all heat exchange parameters relevant to this experiment.They are very similar to above-mentioned experiment, therefore can not be discussed in detail.Unique real significant difference is that the thermic load of carotid artery chiller is slightly large, because we regulate arterial blood temperature to lower temperature, equally, the thermic load of jugular vein heater is also slightly large, because the outlet temperature of 43 DEG C is constant, but inlet temperature is lower than example above, therefore more caloric requirement is added in venous blood.

Experiment C:

The object of this program is patient is exposed in two temperature plateaus.First temperature plateau is will reach 44 DEG C at the treatments period patient temperature of 4 hours, and then, patient temperature will be allowed to drop to 42 DEG C, and keep this temperature until after 12 hours.The object of this variations in temperature is effectively to utilize temperature decrease phenomenon, and this obtains clinical observation in whole-body hyperthermia test, and recognizes that cell carcinogenesis tissue is more sensitive to temperature be exposed to high temperature than in the past under.

In addition, during the infrared heating system producing long-wavelength infrared radiation has been added to and has arranged.The infrared ray of long wavelength is considered to the induction being best suited for thermotherapy, because the frequency of this light can go deep into skin permeation, and heat flux distribution is on a quite thick layer tissue, and this will contribute to preventing from scalding.Infrared lamp can induce heat up to 1000 watts to patient, and control by ratio control system, when the core temperature of patient reaches required temperature, this system can reduce radiant output gradually.Once reach required temperature, infrared lamp will be closed.If core temperature drops to lower than required temperature levels, infrared lamp will reopen, until core temperature turns back to setting value, once core temperature reaches target temperature, the ON/OFF of infrared lamp can be caused again to circulate.

Operation system setting:

Tremulous pulse chiller will be installed in a left side, and RICA maintains under brain compares the relatively cool temperature of thermotherapy temperature that below patient's neck contacts at one.

The arterial pressure of internal carotid artery slightly will increase than the normal arterial pressure of patient, and this will be conducive to blood and flow through carotid artery instead of vertebra/basilar artery.

In this case, the blood heat flowing to internal carotid artery will be adjusted to about 37 DEG C or lower.Accurate blood heat will be recycled and controlled, this circulation be intended to keep from brain backflow be about 37.3 DEG C by the venous blood temperature of internal jugular vein.The turnover rate of controlled circulation upgrades once for every 60 seconds.If flow to the blood heat of internal jugular vein downwards higher than 37.3 DEG C, the setting value of arterial blood chiller will be reduced 0.05 DEG C.Otherwise if the blood heat flowing to internal jugular vein is downwards lower than 37.3 DEG C, the setting value of arterial blood chiller will be increased 0.05 DEG C.

Heater is installed on internal jugular vein.

Heater, by the warm blood flowing to internal jugular vein downwards, makes blood heat in the hyperthermia treatment of initial 4 hours, reach about 43.75 DEG C, and meanwhile, our target is the downward core temperature of cervical region is 44 DEG C.

Setting value (4-12 hour) will be lowered by 41.75 DEG C in second hyperthermia treatment, and during this period, the downward core temperature of required cervical region is 42 DEG C.

After 12 hours, blood will be stopped and be pumped across heater, and will be allowed to naturally to flow to internal jugular vein downwards and get back to heart.This will have a cooling effect to patient, because blood heat will about 37.3 DEG C (brain temperature have then lacked 0.3 DEG C)

Infrared heating fluorescent tube is placed on around patient, estimates that maximum heat capacity is 1000 watts.The infrared ray of long wavelength is first-selected, because it more can go deep into skin permeation, is therefore more easily absorbed by vascular system and transports.

The power stage of infrared lamp control by ratio control system.

When core temperature is 37 DEG C, the peak power output that light fixture produces is 1000 watts.1000 watts are considered to the rise time of about 1 hour that enough can realize our needs, but 1000 watts is not so high, thus can not cause skin burn.

Along with when core temperature increases to the setting value of 44 DEG C or 42 DEG C (depending on the time), the output of lamp will decline.This point is very important to preventing from scalding, because be increased to 44 DEG C and in conjunction with the infra-red radiation of 1000 watts, surface temperature may become quite high along with core temperature.

Once reach target temperature, infrared lamp will enter open/close state, and object is the core temperature maintaining the downward goal treatment of patient's neck.

After 12 hours, patient will be allowed to fall back to a normal core temperature, and during this period, arterial blood chiller, by continuing to regulate the blood heat that upwards flows to internal carotid artery to a necessary temperature, is about 37.6 DEG C to keep brain temperature.

Continuation is kept exposed, because infra-red radiation must be less readily available for absorption by the skin by the skin of patient.In order to limit the heat loss to environment, patient may be placed in hatching tent.Probably when promoting core temperature, the basal metabolism of patient can be greater than his heat loss to environment, and now the core temperature of patient may continue to rise, thus higher than the core temperature of expecting.For this reason, the temperature of hatching tent should be enough low, thus make him be greater than his basal metabolism to the heat loss rate of environment.

Experimental result and discussion:

The key temperatures of following the tracks of in experimentation can be seen in fig. 11, and crucial heat transfer parameter is then out drawn in fig. 12.In conjunction with the heat effect of infrared lamp and jugular vein heater, the core temperature of patient can be increased, make it rising to 44 DEG C less than in the time of 1 hour from 37 DEG C.During this period of time, when core temperature reaches 44 DEG C, the thermal output of infrared lamp drops to about 200 watts gradually from about 1000 watts, afterwards, when estimating to be brought down below respectively along with core temperature or to rise higher than design temperature, infrared lamp can enter open/close state, and during this period of time, jugular vein heater will regulate venous blood temperature to 43.75 DEG C.

After 4 hours, be reduced to 41.75 DEG C along with by the adjustment temperature of the venous blood of jugular vein heating devices heat, the design temperature of infrared lamp will drop to 42 DEG C.In the therapeutic process more than 1.7 hours, the core temperature of patient drops to 42 DEG C from 44 DEG C.At this cooling stage, infrared lamp keeps closing, because the core temperature of patient is higher than the design temperature of required 42 DEG C.Be brought down below 42 DEG C once core temperature, after about 5.7 hours, infrared lamp will recover on-off modulation, and make the core temperature of patient stablize required 42 DEG C.After 12 hours, infrared lamp is closed, and neck jugular vein heater is stopped use, and patient is allowed to cool back and falls normal body temperature.Through the cooling of 3 hours, patient can return to a more normal core temperature of 37.6 DEG C.

In whole process, tremulous pulse chiller is used to regulate and upwards flows to the arterial blood temperature of internal carotid artery to brain, keeps the temperature constant of brain at about 37.6 DEG C with this.Before being crossed internal jugular vein heater by pump, the temperature of the venous blood in internal jugular vein returned from brain is monitored.Suppose that the mean temperature of brain approximates internal jugular vein blood heat and adds 0.3 DEG C.If rise to more than 37.3 DEG C in the venous blood temperature of internal jugular vein, the setting value of internal carotid artery chiller will be reduced 0.05 DEG C, and on the contrary, if venous blood temperature is down to less than 37.3 DEG C, the setting value of chiller will be increased 0.05 DEG C.Compare former experiment, the turnover rate of control system drops to 60 seconds, and the rising of temperature is increased to 0.05 DEG C from 0.02 DEG C, to increase the response time of controlled circulation, thus follows the tracks of the rate of temperature change caused by infrared lamp more energetically.

In whole process, we successfully make the core temperature of patient follow a desirable treatment curve, keep brain at a lower temperature simultaneously.In this case, keep brain Wen Yi closely stationary temperature, thus hypothalamus can not be perceived effectively under the downward core temperature of cervical region is exposed on the thermotherapy treatment temperature of lifting.

Experiment D:

This experiment except a crucial exception similar with experiment C.In whole process, we make brain temperature reduce 1 DEG C.In initial one hour, brain temperature drops to 36.6 DEG C from initial value 37.6 DEG C, and keeps whole 12 hours of this temperature.After 12 hours, the temperature of brain is gradually increased to its normal temperature 37.6 DEG C.Being modified of brain temperature is that arterial blood temperature by controlling upwards to flow to internal carotid artery realizes.As before, by measuring the blood heat of the internal jugular vein returned from brain, brain temperature is monitored.In the experiment that this is special, arterial blood is cooled to the low temperature of 35.1 DEG C, to reach 36.6 DEG C of brain temperature of expection.Suppose that the cerebral blood supply of 10% comes from vertebral artery, in this case, it can enter brain with the high core temperature of 44 DEG C.The key temperatures of this experiment and heat penetration curve are plotted in Figure 13 and 14 respectively.

Brain temperature is regulated to have several benefit to a lower value.First benefit is, hypothalamus can run into the temperature lower than the set point needed for it, and therefore patient can feel cold, thus will enjoy the effect that warms of infrared lamp.Second benefit is that patient can not perspire, thus can not cause dehydration and long discomfort.In essence, patient will feel that the fever of the initial stage that same core temperature rises is similar.Although body temperature rises, but still attempt the desired temperature level that reaches lower than hypothalamus, therefore, the reaction of sympathetic nervous system is that patient feels cold, although core temperature is in rising.In this case, hypothalamus is exposed to lower than the set point temperatures needed for it by we, although the core temperature that cervical region raises downwards, the reaction of sympathetic nervous system still can attempt warm health.

Another benefit is, lower temperature will have a protective effect to brain, and offsets any focus that may be produced by the warm arterial blood being entered brain by vertebra/basilar artery by contributing to.Low temperature within the scope of this can not damage brain, but overheated temperature can damage brain.

Scheme E:

Under this scheme, we are by attempting the high temperature of 46 DEG C reaching a few minutes, to kill virus, and antibacterial or the other diseases that this high temperature is reacted to some extent.Such as, HIV (human immunodeficiency virus) has been proved dead in vivo, if can reach sufficiently high temperature.Because human body can not be exposed to the high temperature of 46 DEG C for a long time, so need very rapidly to heat patient to temperature required, keep this temperature long enough just to kill virus or antibacterial, core temperature is fallen back to a more acceptable level then rapidly.

Operation system setting:

In order to very rapidly heat patient, patient will be immersed in the water-bath of 47 DEG C.Fast Heating and cooling are necessary, because we want to realize a target temperature within the very concrete time, but we want minimizing patient in the cycle of heating up and lower the temperature to expose the time at high temperature.

Tremulous pulse chiller will be installed in a left side, to keep brain at a relatively cold temperature on RICA.

The arterial pressure of internal carotid artery slightly will increase than the normal arterial pressure of patient, to make blood flow through carotid artery instead of vertebra/basilar artery.

Heater can not be installed on internal jugular vein.

In view of water-bath can transmit a large amount of heats to patient, the effect that the blood do not heated flowing to internal jugular vein under subtend carries out cooling is quite slight.

Secondly, in this case, expose heart has suitable at slightly low temperature, therefore, is mixed temperature slightly low for the thermotherapy treatment temperature that contributes to keeping heart more downward than cervical region by the removing heat from blood from internal jugular vein with other venous blood.

Suppose that heart blood discharge amount is 5 liters/min and cervical region obtains the blood of 1 liter/min from heart, the blood mean temperature so entering heart by be to flow to core temperature heart blood flow and with the weighted average of the blood flow from internal jugular vein of lower temperature.

After patient keeps the core temperature of 46 DEG C to reach 5 minutes, patient will be soaked in the psychrolusia of 30 DEG C, more promptly his core temperature is returned to normal level, this cools than him soon in cool air.

Experimental result and discussion:

The key parameter of temperature is in fig .15 drawn, and the heat transfer parameter of key is in figure 16 drawn.When time=0 minute time, patient is immersed in downwards the water-bath of 47 DEG C from trunk.Water is circulated by jet pump, to guarantee compulsory convection current, thus makes patient obtain good conduction of heat.After about 1 minute, core temperature starts to increase sharply.When time=5 minutes time, core temperature has reached 43 DEG C.Because the major part of cerebral blood flow is provided by internal carotid artery, so the blood flowing through internal carotid artery is adjusted to about 37 DEG C, the temperature of brain increase only 0.6 DEG C than original 37.6 DEG C, reaches 38.2 DEG C.When time=13 minutes time, the target temperature of 46 DEG C is reached.Present brain temperature is 38.6 DEG C, and it remains very reasonably temperature.The increase of brain temperature is a function flowing through carotid artery and vertebrarterial blood flow volume ratio.In this case, because we slightly increase carotid arterial pressure, thus the cerebral blood flow of about 90% to seem supply by carotid artery, and the cerebral blood flow of about 10% remains and is supplied by vertebral artery.Therefore, the mean temperature of brain is approximately:

T _cerebral＝0.9×T _carotid+0.1×T _vertebral+0.6℃

0.6 DEG C that supposes here is the temperature difference between arterial blood and brain.

Here, Tcarotid is maintained at about 37 DEG C, and Tvertebral then increases pari passu along with the rising of core temperature, and after 13 minutes, effectively reach about 46 DEG C.Its result is the average brain temperature of 38.6 DEG C, and this is completely in acceptable limit.If necessary, the blood heat flowing through tremulous pulse chiller can be reduced to 36 DEG C, thus causes Tcerebral to be normal 37.6 DEG C.

Closely can follow the tracks of the mean temperature of brain according to the blood heat flowing to internal jugular vein downwards, just have some little negative bias to move.In view of the main method removing the heat produced by brain transfers in cerebral blood flow by heat, therefore brain is usually than the venous blood temperature height about 0.3 DEG C flowing out brain.

The blood heat of flowing out from arterial blood chiller (100) keeps being in close proximity to 37 DEG C whole process.After about 7 minutes, owing to being used to the finite gain of the ratio control system of regulating system temperature, we start to see that Tcarotid has a very little increase.The delayed large thermal capacity by foregoing sterilized water bathing 106 of this time causes.Maximum Tcarotid=37.18 DEG C time=12 minutes time realize.

Time=18 minutes time, core temperature will remain on 46 DEG C in required 5 minutes always, and the cooling water that the water of water-bath is exchanged into 30 DEG C falls back to rapidly more comfortable temperature to make patient temperature.After about 5 minutes, the core temperature of patient reduces to nearly 38 DEG C, and cold water is taken out by from water-bath.

Figure 16 shows the various diverse ways that heat is transferred to patient.The heat transfer mechanism of most advantage is conducted heat to patient with water-bath.Maximum transfer of heat be time=0, realize when water temperature is 47 DEG C, and skin surface temperature only has an appointment 34 DEG C, thus causes a large temperature difference and maximum heat transfer results.Along with the increase of patient surface temperature, core temperature also starts to increase, and the starting to increase of skin temperature makes the heat transfer of hot bath to patient start to decline.Heat transfer is approximately:

${\stackrel{\·}{Q}}_{\mathrm{Water}}=(T_{\mathrm{water}}-T_{\mathrm{skin}})*h*A$

Here:

T _waterthe temperature of=water-bath

T _skinthe skin surface temperature of=patient

The effective convection coefficient of h=from water-bath to patient

Patient's A=submergence surface area in a water bath.

When time=0 time, we observe heat transfer rate and are about 12 kilowatts, and then, along with the minimizing of the increase of core temperature and the temperature difference between water and skin, heat transfer rate starts exponentially to decay.When time=18 minutes time, the cold water of 30 DEG C is introduced into water-bath, and the temperature difference between the skin of patient and water is 16 DEG C, and therefore, a very large radiating effect is implemented, and heat is removed by from patient with it with the speed of 19 kilowatts.The body temperature of patient quickly falls to 38 DEG C, and then, cooling water is taken out by from water-bath.

Another leading diabatic process is removed from arterial blood by heat by arterial blood chiller 100.Have the arterial blood of the heating of patient's core temperature to flow to chiller, heat is deleted by q.s, turns back to about 37 DEG C to make blood heat.Approximate heat loss can be calculated by following formula:

Here:

it is the rate of heat dissipation of the arterial blood flowing through chiller 100.

it is the blood flow by chiller represented by milliliters/second.

ρ is the density of blood represented with grams per milliliter.

C _pit is the concrete heat in blood represented with joule/gram degree.

When time=16.5 minutes time chiller rate of heat dissipation reach the highest, be 604 watts, when core temperature is 46.24 DEG C, arterial blood exits chiller 100, is 37.17 DEG C.

Also a small amount of heat loss to environment is had.Although be difficult to weigh the heat loss to environment, we estimate, when core temperature reaches the highest, nearly 125 watts of heats are scattered and disappeared to environment, and it mainly by breathing cold air, and makes shoulder, and cervical region and head contact realize to surrounding air.

It should be noted that metabolism based on final origin of heat.The basal metabolism of a typical adult is about 84 watts at ambient temperature, along with core temperature rises to 41.8 DEG C, basal metabolism then exponentially increase be about 162 watts.

Because we do not use venous blood heater 200 in this scheme, so the blood flowed back to from brain by internal jugular vein is no longer reheated, thus make the blood of arrival heart more lower slightly than core temperature.The blood heat entering heart through channels vein can by being approximately as follows to the weighted average of two blood flows:

T _{vanae_cava}＝f _cervical*T _Jugular+(1-f _cervical)*T _Core

Here:

F _cervicalequal a part of cardiac output supplied by brain, be about 0.2.

T _jugularit is the temperature of the venous blood returned from brain.Time=16 minutes time, it equals 38.8 DEG C.

T _corebe core temperature, we estimate, the non-jugular vein blood heat returned from other position of health is approximately the core temperature of health.

Use this approximation, we find, when time=16 minutes time, the blood heat being entered heart by channels vein is 44.7 DEG C, and now core temperature is 46.28 DEG C.Make heart experience the temperature slightly lower than core temperature and be conducive to unduly tired cardiac muscle while increasing the core temperature realized.In addition, the blood heat being entered pulmonary by pulmonary artery also will be about at 44.7 DEG C of these slightly low temperature, and this contributes to delaying breaking of in alveolar ABB.

Finally, if patient is a male, scrotum can be wrapped in a watertight plastic bag, and the cooling water of a tubule can be pumped in bag, to guarantee in the water that testis not to be exposed in the water of 47 DEG C at a lower temperature.

In a word, under this scheme, we successfully made the core temperature of patient bring up to 46 DEG C in 13 minutes, and temperature remains on 46 DEG C and reaches 5 minutes, and to reach desirable therapeutic effect, after then cooling 5 minutes in psychrolusia, core temperature is brought back into 38 DEG C.Under brain temperature remains on the thermotherapy temperature significantly lower than treatment, not more than 38.7 DEG C.The arterial blood upwards flowing to internal carotid artery is cooled by arterial blood chiller and in whole hyperthermia process, is adjusted to about 37 DEG C.Carotid arterial pressure slightly increases to impel blood flow to flow through carotid artery relative to vertebral artery, and is forced through this arterial blood of returning of circulating of Willie and flows into those regions usually supplied by vertebral-basilar artery.From the venous blood that brain flows back to, by internal jugular vein, no longer reheat.Although this has radiating effect to core temperature, this is very little to compare heats that tepidarium brings.In addition; because be mixed with from the cold-blooded of internal jugular vein other the warm blood returned from other position of health; thus at the temperature that heart and pulmonary are exposed to a little less than core treatment body temperature; the impact of ABB from the core temperature promoted of cardioprotection and lung can be conducive to, thus extend maximum attainable treatment temperature.

Experiment F:

This scheme except two exception to above described in be similar.

First, in this case, we are by chiller extra for interpolation one, and carry out the venous blood of cooling for reflux to heart with it.The object done like this be before venous blood returns heart preferential cooling it, to make the ABB of heart and lung be exposed to more than at the low temperature of the thermotherapy temperature for the treatment of, thus higher temperature can be implemented and not damage heart or pulmonary.

Secondly, because we are striving for the rising of thermotherapy temperature, so we will regulate the temperature of brain to the temperature lower than typical normal brain temperature 37.6 DEG C.This will be done when similar experiment D, wherein upwards flows to carotid arterial blood temperature and is adjusted to a necessary value, to maintain the venous blood that returned by brain by internal jugular vein a desirable temperature.This will contribute to any high-temperature region of dissipating by directly flowing to vertebrarterial warm arterial blood and causing.In this case, before patient is immersed in tepidarium, the temperature of brain will be adjusted to 36.6 DEG C always, and this is lower about 1 DEG C than a typical brain temperature.

Operation system setting:

In order to very rapidly heat patient, patient will be immersed in the water-bath of 47.5 DEG C.Fast Heating and cooling are necessary because we want realize target temperature within very concrete time, but we want heat up and cooling cycle in reduce patient and expose time at high temperature.

Tremulous pulse chiller is installed in a left side, on RICA, to keep brain at relatively cool temperature.The arterial blood temperature flowing through chiller is controlled system fading margin, and this control system attempts to keep brain temperature at 36.6 DEG C, and compared with normal brain temperature is low about 1 DEG C.The feedback of control system returns from brain by measuring, at internal jugular vein, and in the temperature by the venous blood before chiller.

The arterial pressure of internal carotid artery is added to the normal arterial pressure a little more than patient, and to impel blood flow by carotid artery instead of vertebra/basilar artery, and by Willie, this is recycled to those areas usually supplied by vertebral-basilar artery from carotid artery to drive arterial blood.

Heater can not be installed on internal jugular vein.

On the contrary, extra chiller 100 by be installed on internal jugular vein or arm vein on, an or combinational circuit, one of them conduit is inserted in another conduit on internal jugular vein and is then inserted on the vein of arm.

In this case, venous blood is cooled to about 30 DEG C, and the venous blood of about 1 liter per minute is passed through this system, makes the blood heat being back to heart have sizable minimizing.

In view of water-bath can transmit a large amount of heat to patient, the cooling effect of the venous blood of cooling can not stop required thermotherapy temperature to be implemented.

Secondly, by cooling venous blood, venacaval inflow heart blood and will be lower than thermotherapy treatment temperature in the blood heat of Pulmonic inflow pulmonary, this will be conducive to the highest treatment temperature of raising or the extended treatment time does not damage heart simultaneously.

In this case, under heart and pulmonary's blood gas barrier be maintained at lower temperature, so patient can be maintained at 46 DEG C within the long period being about 14.5 minutes.Once reach required treatment time, patient will be promptly immersed in the psychrolusia of 30 DEG C, returns to normally to make the core temperature of patient.

Experimental result and discussion:

In view of many aspects and the above-mentioned situation of experiment are similar, we will mainly concentrate in the difference of key.In fig. 17, crucial heat transfer parameter then as shown in figure 18 in key temperatures display.

In this case, extra chiller 100 is installed on internal jugular vein.Along with core temperature starts to increase to above 37 DEG C, venous blood is directly passed through extra chiller, makes its temperature drop to about 30.1 DEG C.Along with the rising of the core temperature of patient, the whole blood finally from internal jugular vein will be passed through extra chiller significantly.This will cause the linear reduction of the venous blood temperature flowing into internal jugular vein downwards, namely drops to 30.1 DEG C (times=7 minutes) from initial temperature 37.3 DEG C (time=0 point).

The warm venous blood that removing heat from blood due to internal jugular vein and other position from health return mixes, and makes venacaval blood heat more much lower than body temperature.Our similar formula discussed above, think:

T _{vanae_cava}＝f _cervical*T _Jugular+(1-f _cervical)*T _Core

In this case, the blood of about 1 liter per minute is directly passed through extra chiller, and is reinjected in internal jugular vein with the temperature of 30.1 DEG C.Cardiac output is approximately 5 liters per minute.Such f _cervica=0.2, T _core=46.6 DEG C, the blood heat entering heart through caval vein is then 43.2 DEG C, and this is lower than body temperature 3.4 DEG C, considerable.This will be conducive to cardiac muscle and pulmonary, because it is lower than core temperature to the blood of alveolar to flow through pulmonary vein.

Compared with former scheme, other differences are that this patient is allowed to remain on 46 DEG C for 14 minutes, because brain, under heart and lung are preferentially cooled and are exposed to the temperature far below 46 DEG C.In this case, under the temperature of brain is maintained at the temperature more lower slightly than normal body temperature, can not more than 37 DEG C, although the downward core temperature of cervical region has brought up to quite high 46.6 DEG C.

Crucial heat transfer parameter as shown in figure 18.In this case, the Q of patient is heated except being used for _waterexception, the heat transfer of every other pattern is all negative and is delete heat from the body of patient, comprising the chiller be placed on patient's internal jugular vein.

Method and system described herein, can be used for being combined with the oxygenate of film gas exchange or other types, to provide oxygen to brain, such as in case of the cardiac arrest, this may cause the rising of thermotherapy temperature, such as, above-mentioned 44 DEG C.This system also can be used for coordinating haemodialysis control unit, to adjust or to maintain the blood chemistry in long-time thermotherapy treatment.These two systems are well-known in this area, and they can combine with the method and apparatus of suggestion.In addition, as mentioned above, body core temperature higher during thermotherapy treatment may allow the medicine using effective dosage lower, or provides convenient to diagnotor.

the embodiment substituted

The first-selected embodiment of equipment uses the bypass circuit that volume is little, only need like this to make relatively little blood flow volume be transferred to bypass circuit within any one time, but heating and/or chiller provide the high flow rate of 50 to 1000 ml/min, general about 400 ml/min, and provide enough thermal capacity to the blood flow of cooling or heating fast, such as, in the scope of about 300 watts or more than 300 watts.Preferably the internal volume reducing heat exchanger during surface area Datong District of heat transfer is to greatest extent allowed to the design of bypass circuit heat exchanger.This will be of value to this system also can with sufficiently high pressure, and supply blood flows to brain, by this circulation of Willie, arrives the brain region usually supplied by Vertebral-basilar artery.Therefore, this system can provide effectively and cool rapidly brain to keep the temperature difference with core temperature.It is preferred that this system allows the heat management scope of blood heat relative to normal body temperature from approximately-7 DEG C to about 10 DEG C.Rapid temperature increases after this system can also provide treatment or be cooled to target temperature.

If needed, this system also can provide temperature to regulate from the blood flow of brain backflow to by heating or cooling.There has minimal normal blood flow to interrupt, and this system also likely allows to make patient to keep consciousness and comfortable, such as, under the neck of prolongation in thermotherapy treatment.

Although embodiment of the present invention have been described in detail and have illustrated, but the embodiment substituted or diverse ways also will be appreciated, system of the present invention and equipment will be used, such as, cool tremulous pulse or venous blood flow with one or more bypass circuit and heat blood flow with one or more bypass circuit.Therefore, the blood flow temperature returning heart and pulmonary from brain is also likely adjusted to suitable temperature, too high to protect these organs to avoid temperature.In addition, system in other embodiments and instrument also may be applicable to other diagnosis or treatment procedure, relative to cervical region with the thermotherapy temperature at other positions of lower body, require there to remain normal or warm close to normal brain (brain core).

Although the referred use of concrete artery and vein in the above-described embodiment, other suitable blood vessels also can be used.Such as, mainly should be mentioned that the internal carotid artery of supply blood flow to brain.But depend on that inside and outside carotid branch is local, conduit can be placed on carotid artery or internal carotid artery potentially.In some cases, if their separation is too high in the position of cervical region, needs are placed on neck arteries and veins by conduit, because it is easily accessed.In this case, the blood after process will upwards flow in inside and outside carotid artery.In the case of the latter, need little by little extra blood treatment to supply Liang Ge branch.In other cases, inlet ducts may be placed on neck arteries and veins, and delivery channel may be placed on internal carotid artery, because it is above neck and the below of cut-point.In addition, the tip of delivery channel can be pushed to internal carotid artery to surmounting neck arteries and veins bifurcation, makes the blood flow of cooling flow to internal carotid artery.

When a bypass circuit is coupled to arm, the blood vessel of lower limb or trunk, will be selected a suitable blood vessel by medical practitioner.Such as, on arm, larger blood vessel is axillary artery and vein, brachial artery and vein and head side artery and vein.

Other known blood processing apparatus also will be appreciated, extra element and sensor can be provided to one or more bypass circuits, such as allow embolus (clot or bubble), or to the detection of terminal (being used for introducing treatment or the blood stream of diagnostic reagent) and filtration.Such as, when start-up operation, conventional program will be used to prepare and start bypass circuit and eliminate bubble.This system may comprise, such as additional sensors, and it is used to monitor temperature, pressure and the flow at other points, and monitoring shows the core temperature of patient and the suitable parameter of core brain temperature or other vital signs.

In addition, although described the Therapeutic Method implementing the following thermotherapy of cervical region in detail according to the method for embodiment, but system as herein described and instrument may also have other application programs, it can be lowered the temperature rapidly to brain by relative body, and keeps the temperature difference between brain core temperature and core temperature.

Such as, tremulous pulse chiller also can be used to promptly cool brain to a low temperature state, to prevent or to reduce in sudden cardiac arrest, cerebral concussion, contingency or the injured cerebrum ischemia that may cause or oxygen time, to the infringement of brain.To connect on tremulous pulse chiller to carotid artery and cooling supply brain blood brain temperature can be made sharply to decline, and may alleviate patient is sent to hospital the brain injury before treatment.

Industrial usability

A system, instruments and methods provides extracorporeal blood treatment.Particularly blood processing apparatus and system provide temperature below to brain temperature and neck portion of body control poor; it is poor that method then provides the body temperature setting up and maintain below cervical region; keep close to normal brain temperature, with the impact protecting brain not to be subject to long or extreme low temperature or thermotherapy simultaneously.Such as, first bypass circuit, has brain blood circulation heat exchanger, and its keeps one close to normal blood heat, and second bypass circuit be to cervical region below blood circulation provide heat treatment, such as thermotherapy, thus cause the temperature difference of relative cerebral circulation.These systems and instrument have a lot of application, such as, thermotherapy can be used to carry out Diagnosis and Treat.Advantageously, the high-temperature process of such as time expand or more than 42 DEG C may be applicable to thermotherapy treatment cancer, the disease that infective bacterial or virus cause, and avoids simultaneously or reduces the adverse effect to brain and other thermally sensitive tissues.

Balance cooling brain also be can be used to a low temperature state to the control difference of brain temperature and body temperature, and the body temperature simultaneously below cervical region reaches or close to Normal Kernel body temperature.This application program also can in sudden cardiac arrest, and injury of head causes cerebral concussion, prevents brain injury when contingency or apoplexy.

Although embodiment of the present invention have been described in detail and have illustrated; but we still recognize with will be clear that; here working of an invention scheme that is described and that illustrate is illustration and example; and the present invention is not by the restriction of these embodiments disclosed herein; current scope of the present invention is only limited to appended claim, and the embodiment in the right of all the application of falling into all belongs to protection scope of the present invention.

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Claims (32)

1. a system for thermotherapy treatment, be characterized in: i) it has external cooling (100, 400, 600) the hands section of the cerebripetal blood flow of at least one carotid artery stream is passed through from health, ii) there is the hands section of health to required thermotherapy temperature of below heating cervical region simultaneously, it comprises a venous blood flow bypass circuit, this bypass circuit has input equipment (501), for receiving the venous blood flow from brain, output device (502), for connecting the venous blood flow be back in body, with heat exchanger (103), for arranging the temperature regulated from the venous blood flow just now mentioned of brain outflow before returning health, iii) and simultaneously have keep cervical region with lower body under the thermotherapy temperature needed for, and keep brain control device at a lower temperature (300).

2. system according to claim 1, is characterized in that, heater means comprises external heating (200,500,700) is back to health through at least one internal jugular vein blood from brain.

3. system according to claim 1, is characterized in that, heater means comprises one or more extracorporeal blood heaters, infrared lamp, heating lamp, a hot bath, heating installation woollen blanket, radio wave, a couveuse, vicarious woollen blanket.

4. system according to any one of claim 1 to 3, it is characterized in that, external cooling (100,400,600) means of blood comprise chiller, and chiller comprises extracorporeal circulation of blood bypass circuit, extracorporeal circulation of blood bypass circuit comprises a pump (104), heat exchange means (108,106,103), temperature sensor (113,114) control device (300) mentioned, and is in the past used to regulate target temperature and from the cerebripetal blood flow of carotid artery stream.

5. system according to any one of claim 1 to 3, it is characterized in that, venous blood flow bypass circuit comprises heater, and heater comprises extracorporeal circulation of blood bypass circuit, extracorporeal circulation of blood bypass circuit comprises a pump (104), heater and heat exchanger (208,106,103), temperature sensor (113,114) control device (300), and wherein mentioned in the past is used to the blood flow regulating target temperature and flow to health from jugular vein.

6. system according to claim 1, it is further characterized in that, the means arriving the blood flow of heart and pulmonary through internal jugular vein that it has external cooling (100) to return from brain.

7., for a system for extracorporeal blood treatment, be characterized in:

I) artery blood flow bypass circuit has the input medium (101) and the link cerebripetal output means of carotid blood stream (102) that receive the artery blood flow flowed out from health; First heat exchange means (103) is used for regulating the temperature flowing to the carotid artery by-pass blood flow of brain just now mentioned; Pump means (104) is used for the carotid artery flow dose rate flowing to brain controlling just now to mention; Sensor means (114) is used for the temperature of monitor blood flow output, and

II) second heat exchange means refers to the cervical region of heating or cooling patient simultaneously with lower portion to required temperature,

III) control device (300) refers to monitor and forecast artery blood flow bypass circuit simultaneously, to obtain required brain temperature, and just now mentioned second heat exchange means is to obtain required core temperature, wherein the second heat-exchange device comprises a venous blood flow bypass circuit, it has input equipment (501), for receiving the venous blood flow from brain; Output device (502), for connecting the venous blood flow be back in body; Heat exchanger (103), for arranging the temperature regulated from the venous blood flow just now mentioned of brain outflow before returning health; With pump installation (104), for controlling the flow velocity of the venous bypass blood flow just now mentioned.

8. system according to claim 7, it is characterized in that, just now the second heat exchange means mentioned comprises: venous blood flow bypass circuit has the input medium (101) and link venous blood flow that receive the internal jugular vein blood flow flowed out from brain to the output means (102) of health, and heat exchanger (103) is used for regulating the venous blood flow just now mentioned to the temperature of health; Pump means (104) is used for the pressure of the venous bypass blood flow controlling just now to mention and flow; Sensor means (114) is used for the temperature of monitor blood flow output, and the control device just now mentioned (300) further provides and controls output flow and the temperature that venous blood flows to health.

9. the system according to claim 7 or 8, is characterized in that, second heat exchange means wherein comprises one or more extracorporeal blood heater, infrared radiation or infrared lamp, water-bath, water blanket, a couveuse, radio-frequency radiation, radio wave, perceptual woollen blanket.

10. system according to claim 9, is characterized in that, control device is wherein set up and maintained the body temperature of below cervical region and the temperature difference of brain temperature.

11. systems according to claim 7 or 8, is characterized in that, control device wherein set up and maintain in predetermined treatment time relative to the thermotherapy below the cervical region of normal brain temperature.

12. systems according to claim 7 or 8, is characterized in that, control device wherein set up and maintain in predetermined treatment time relative to the low temperature therapy below the cervical region of normal brain temperature.

13. systems according to claim 10, is characterized in that, the temperature difference wherein just now mentioned can be programmed regulation and control in treatments period.

14. systems according to claim 7 or 8, it is further characterized in that, the data that sensor means is used for receiving core temperature and brain core temperature indicate, and the control device in system maintains the required temperature difference between the artery blood flow of the input just now mentioned and the carotid artery flow of output, thus provide the required temperature difference between core temperature and brain core temperature just now mentioned.

15. systems according to claim 14, it is characterized in that, control device maintains the temperature difference between tremulous pulse bypass output and venous bypass output just now mentioned, thus maintains the predetermined temperature difference between the brain temperature of patient and the following core temperature of cervical region.

16. systems according to claim 7 or 8, it is characterized in that, wherein the input and output mode of each respective bypass circuit further comprises conduit and vascular forceps or foley's tube, and their arrange the shunting carotid artery flow by respective bypass circuit at least partially or internal jugular vein blood flow.

17. 1 kinds, for the extracorporeal blood treatment equipment of thermotherapy, comprising:

I) feature of chiller (100) is, artery blood flow bypass circuit has input port (101), is used for receiving the arterial blood flowed out from health, and delivery outlet (102), is used for the cerebripetal artery blood flow of transportation flow; Pump (104) is used for extracting blood out from bypass circuit; The means (108/106/103) of heat exchange are used for cooling blood flow by bypass circuit;

Ii) heater is used for increasing heat to the health below the cervical region of patient simultaneously, it comprises a venous blood flow bypass circuit, this bypass circuit has input equipment (501), for receiving the venous blood flow from brain, with output device (502), for being connected through the thermoregulator venous blood flow from brain and being back to the venous blood flow in body;

Iii) while that control device (300/117) being used for, monitor and forecast is by the artery blood flow temperature of chiller (100), to keep required brain temperature, also monitor and forecast heater is to maintain the downward core temperature of required cervical region.

18. equipment according to claim 17, it is characterized in that, heater (500,700) feature is that artery blood flow bypass circuit has input port (101), be used for receiving the venous blood flow flowed out from brain, with have delivery outlet (102), be used for delivery of intravenous blood flow to health; Pump (104) is used for extracting blood out from bypass circuit; Heat exchange means (208/106/103) is used for heating the blood flow through bypass circuit; Temperature sensor (114) is used for monitoring the temperature exporting blood flow; Just now the control device (300/117) mentioned further provides monitoring and regulates delivery of intravenous blood flow to the output temperature of health higher than the input temp of the venous blood flow returned from brain.

19., according to claim 17 to the equipment according to any one of 18, is characterized in that, heater comprises one or more extracorporeal blood heater, infrared radiation or infrared lamp, water-bath, water blanket, a couveuse, radio-frequency radiation, radio wave, perceptual woollen blanket.

20. equipment according to claim 19, it is characterized in that, control device wherein has operability, keeps the thermotherapy of the core temperature more than 42 DEG C of below cervical region simultaneously, and the temperature difference that maintenance flows between the arterial blood temperature of brain and core temperature, to maintain close to normal brain temperature.

21. equipment according to claim 17 or 18, is characterized in that, wherein chiller can receive the blood flow of the input of 42 DEG C or higher temperature, and cooling flows to the arterial blood at least 5 DEG C of brain.

22. equipment according to claim 17 or 18, it is characterized in that, wherein one or more above-mentioned heaters or chiller comprise heating and cooling element (108/208), enable the temperature of output blood flow be adjusted to required higher or lower temperature relative to the temperature of input blood.

23. equipment according to claim 17 or 18, is characterized in that, can provide the flow velocity of about 400 ml/min in every bypass circuit.

24. equipment according to claim 17 or 18, it is characterized in that, wherein each bypass circuit can provide scope from the flow velocity of 50 to 1000 ml/min.

25. equipment according to claim 17 or 18, is characterized in that, wherein each respective heating and/or chiller have the heat-exchange capacity of at least 100 watts.

26. equipment according to claim 17 or 18, is characterized in that having operability, to maintain the temperature difference of between a core temperature and a core brain using warming therapy at least 4 DEG C.

27. equipment according to claim 17 or 18, it is characterized in that, wherein the feature of heat exchange means is the clam shell portion that heat exchange mass comprises first and second, it establishes the channel of pumping blood between the first and second clam shell portion, and wherein on heat transfer direction, the cross-sectional width of channel is obviously greater than the thickness of channel.

28. equipment according to claim 27, is characterized in that, wherein the clam shell portion of first and second can be separated, so that cleaning and sterilization, thus heat exchanger are reused.

29. systems according to claim 1, it is characterized in that, comprise a sensor, to monitor the venous blood temperature refluxed from brain through internal jugular vein, as an index of brain temperature, this temperature is used to come the external cooling (100 of adjustment, 400,600) control device (300) of temperature provides feedback, this external chiller for regulating the blood heat being delivered to brain, to reach required brain temperature.

30. systems according to claim 1 or 29, it is characterized in that, wherein for the means of regulating and controlling by the blood flow rate of tremulous pulse chiller (100), provide a carotid arterial pressure with the mean arterial pressure of patient or higher than the mean arterial pressure of patient.

31. systems according to claim 30, it is characterized in that, by to the inlet wire (401 be placed on carotid artery, 601) conduit and outlet (402,602) operation of conduit, make its control device for exceeding certain level along with bypass circuit Hemodynamic environment and the inlet wire arterial blood temperature that produces reduces by sensing, thus the reverse flow of the arterial blood of inlet wire and outlet detected.

32. systems according to claim 31, it is characterized in that, it has operability, needing to initiate in the range of flow needed for the reverse flow between inlet wire and outlet or more than this scope, flow velocity is regulated and controled by tremulous pulse chiller (400,600).